Attach to Form 990 or Form 990-EZ.
See separate instructions.
Information about Schedule A (Form 990 or 990-EZ) and its instructions is at www.irs.gov/form990.
| (i) Name of supported organization | (ii) EIN | (iii) Type of organization (described on lines 1- 9 above or IRC section (see instructions)) | (iv) Is the organization in col. (i) listed in your governing document? | (v) Did you notify the organization in col. (i) of your support? | (vi) Is the organization in col. (i) organized in the U.S.? | (vii) Amount of monetary support | |||
|---|---|---|---|---|---|---|---|---|---|
| Yes | No | Yes | No | Yes | No | ||||
| Total | |||||||||
Calendar year (or fiscal year beginning in) ![]() |
(a) 2009 | (b) 2010 | (c) 2011 | (d) 2012 | (e) 2013 | (f) Total | |
|---|---|---|---|---|---|---|---|
| 1 | Gifts, grants, contributions, and membership fees received. (Do not include any "unusual grants.") .... | 1,202,798 | 2,355,777 | 1,280,861 | 1,445,229 | 1,357,431 | 7,642,096 |
| 2 | Tax revenues levied for the organization's benefit and either paid to or expended on its behalf....... | ||||||
| 3 | The value of services or facilities furnished by a governmental unit to the organization without charge.. | ||||||
| 4 | Total. Add lines 1 through 3 | 1,202,798 | 2,355,777 | 1,280,861 | 1,445,229 | 1,357,431 | 7,642,096 |
| 5 | The portion of total contributions by each person (other than a governmental unit or publicly supported organization) included on line 1 that exceeds 2% of the amount shown on line 11, column (f).. | 1,511,981 | |||||
| 6 | Public support. Subtract line 5 from line 4. | 6,130,115 | |||||
Calendar year
(or fiscal year beginning in) ![]() |
(a) 2009 | (b) 2010 | (c) 2011 | (d) 2012 | (e) 2013 | (f) Total | |
|---|---|---|---|---|---|---|---|
| 7 | Amounts from line 4.. | 1,202,798 | 2,355,777 | 1,280,861 | 1,445,229 | 1,357,431 | 7,642,096 |
| 8 | Gross income from interest, dividends, payments received on securities loans, rents, royalties and income from similar sources... | 7,427 | 12,029 | 18,834 | 12,225 | 8,138 | 58,653 |
| 9 | Net income from unrelated business activities, whether or not the business is regularly carried on.. | ||||||
| 10 | Other income. Do not include gain or loss from the sale of capital assets (Explain in Part IV.).. | ||||||
| 11 | Total support (Add lines 7 through 10). | 7,700,749 | |||||






Calendar year (or fiscal year beginning in) ![]() |
(a) 2009 | (b) 2010 | (c) 2011 | (d) 2012 | (e) 2013 | (f) Total | |
|---|---|---|---|---|---|---|---|
| 1 | Gifts, grants, contributions, and membership fees received. (Do not include any "unusual grants.") . | ||||||
| 2 | Gross receipts from admissions, merchandise sold or services performed, or facilities furnished in any activity that is related to the organization's tax-exempt purpose...... | ||||||
| 3 | Gross receipts from activities that are not an unrelated trade or business under section 513.. | ||||||
| 4 | Tax revenues levied for the organization's benefit and either paid to or expended on its behalf... | ||||||
| 5 | The value of services or facilities furnished by a governmental unit to the organization without charge.. | ||||||
| 6 | Total. Add lines 1 through 5. | ||||||
| 7a | Amounts included on lines 1, 2, and 3 received from disqualified persons... | ||||||
| b | Amounts included on lines 2 and 3 received from other than disqualified persons that exceed the greater of $5,000 or 1% of the amount on line 13 for the year. | ||||||
| c | Add lines 7a and 7b.. | ||||||
| 8 | Public support (Subtract line 7c from line 6.) | ||||||
Calendar year (or fiscal year beginning in) ![]() |
(a) 2009 | (b) 2010 | (c) 2011 | (d) 2012 | (e) 2013 | (f) Total | |
|---|---|---|---|---|---|---|---|
| 9 | Amounts from line 6... | ||||||
| 10a | Gross income from interest, dividends, payments received on securities loans, rents, royalties and income from similar sources.. | ||||||
| b | Unrelated business taxable income (less section 511 taxes) from businesses acquired after June 30, 1975. | ||||||
| c | Add lines 10a and 10b. | ||||||
| 11 | Net income from unrelated business activities not included in line 10b, whether or not the business is regularly carried on. | ||||||
| 12 | Other income. Do not include gain or loss from the sale of capital assets (Explain in Part IV.) .. | ||||||
| 13 | Total support. (Add lines 9, 10c, 11, and 12.).. | ||||||




| Facts And Circumstances Test |
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| Explanation |
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| Software ID: | |
| Software Version: |
Attach to Form 990 or 990-EZ.
Information about Schedule O (Form 990 or 990-EZ) and its instructions is at| Return Reference | Explanation |
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| FORM 990, PART III, LINE 4A | (CONTINUED) STUDY TITLE: LONG TERM OUTCOME FOLLOW-UP OF THE RAD001 B253 STUDY, EVEROLIMUS FOR THE PREVENTION OF ALLOGRAFT REJECTION AND VASCULOPATHY IN CARDIAC-TRANSPLANT RECIPIENTS SPONSOR: NOVARTIS PROJECT SUMMARY: SURVIVAL FOR TRANSPLANT RECIPIENTS IS STILL LIMITED BY CARDIAC ALLOGRAFT VASCULOPATHY (CAV), INFECTIOUS COMPLICATIONS, MALIGNANCY, AND REJECTION. IN THE LANDMARK HEART TRANSPLANT STUDY RAD001 B253 WITH ALL GROUPS GIVEN CYCLOSPORINE, BOTH DOSES OF EVEROLIMUS (1.5 AND 3 MG/DAY) WERE SUPERIOR TO AZATHIOPRINE FOR EFFICACY FAILURE AT 6, 12, AND 24 MONTHS POST TRANSPLANTATION. THIS FINDING WAS PRIMARILY DUE TO A REDUCTION IN THE INCIDENCE OF ACUTE REJECTION (ISHLT GREATER THAN OR EQUAL TO GRADE 3A) IN THE EVEROLIMUS GROUPS. THE RAD B253 STUDY ALSO CONFIRMED THAT EVEROLIMUS APPEARED TO BE MORE BENEFICIAL THAN AZATHIOPRINE IN REDUCING THE SEVERITY AND INCIDENCE OF CAV AT 1-YEAR POST TRANSPLANTATION. HOWEVER, THE LONG TERM BENEFIT OF EVEROLIMUS IN HEART TRANSPLANT PATIENTS HAS YET TO BE ESTABLISHED AND THUS, A STUDY EVALUATING LONG-TERM OUTCOMES IS WARRANTED. THE PURPOSE OF THIS STUDY IS TO COMPARE THE 10-YEAR OUTCOMES OF CARDIAC TRANSPLANT PATIENTS ORIGINALLY RANDOMIZED TO EVEROLIMUS 1.5MG, EVEROLIMUS 3.0MG AND AZATHIOPRINE GROUPS FROM THE MULTI-CENTER RAD001 B253 STUDY. THESE OUTCOMES INCLUDE SURVIVAL, CARDIAC ALLOGRAFT VASCULOPATHY (CAV) BY ANGIOGRAPHY, AND NON-FATAL MAJOR ADVERSE CARDIAC EVENTS. THIS IS AN INVESTIGATOR-INITIATED STUDY WHERE CEDARS-SINAI IS SERVING AS THE COORDINATING SITE, GATHERING LONG-TERM FOLLOW UP DATA ON PATIENTS FROM THE ORIGINAL STUDY. STUDY TITLE: ADVANCED HEART DISEASE REGISTRY STUDY SPONSOR: INTERNAL PROJECT SUMMARY: HEART FAILURE IS A COMPLEX PROGRESSIVE MULTISYSTEM DISEASE STATE AFFECTING OVER 5 MILLION AMERICANS WITH SIGNIFICANT MORBIDITY AND MORTALITY. THERE HAS BEEN SIGNIFICANT IMPROVEMENT IN THE SURVIVAL OF PATIENTS DIAGNOSED WITH HF OVER THE RECENT YEARS WITH MUCH BEING OWED TO MEDICAL THERAPY ADVANCES AND A DEEPER KNOWLEDGE OF THE NEURO-HORMONAL CONTRIBUTION TO THIS CONDITION. WITH A YEARLY INCIDENCE OF 500,000 NEWLY DIAGNOSED HEART FAILURE PATIENTS, HEART FAILURE CONTINUES TO BE A MAJOR PUBLIC HEALTH BURDEN, AND IS THE MOST COMMON REASON FOR HOSPITAL ADMISSION FOR PATIENTS ABOVE 65 YEARS OF AGE. DESPITE SIGNIFICANT IMPROVEMENT IN MORBIDITY AND MORTALITY OVER TIME, HEART FAILURE REMAINS A CHRONIC DISEASE CHARACTERIZED BY RECURRENT DECOMPENSATIONS AND PERSISTENT SYMPTOMS. THE PURPOSE OF THIS CLINICAL RESEARCH IS TO RETROSPECTIVELY REVIEW DATA ON PATIENTS DIAGNOSED WITH HEART FAILURE, INCLUDING THOSE WHO ARE MAINTAINED ON MEDICAL THERAPY, THOSE WHO RECEIVE A HEART TRANSPLANT AND THOSE WHO RECEIVE MECHANICAL CIRCULATORY SUPPORT. THE RESEARCH WILL ADDRESS A VARIETY OF FACTORS INCLUDING QUALITY OF LIFE, CLINICAL OUTCOMES, MEDICAL AND SURGICAL THERAPIES, COMPLIANCE, USE OF INOTROPES, GENDER DIFFERENCES, AGE DIFFERENCES, SEXUAL DYSFUNCTION, VENTRICULAR ASSIST DEVICES, OBESITY, DIET, NUTRITION, PSYCHOSOCIAL FACTORS, PATHOLOGY DATA, LAB VALUES, SPIRITUALITY COUNSELING, PALLIATIVE CARE INTERVENTIONS, REHOSPITALIZATIONS, CLINICAL INTERVENTIONS, HEMODYNAMIC CHANGES, AND THE IMPACT ON BOTH SHORT-TERM AND LONG-TERM SURVIVAL AND QUALITY OF LIFE. BY EVALUATING THE DATA OF ALL OF OUR ADVANCED HEART DISEASE PATIENTS IN ONE COMPREHENSIVE DATABASE STUDY, WE HOPE TO IMPROVE OUR UNDERSTANDING OF HEART FAILURE AS WELL AS IMPROVE THE QUALITY OF LIFE OF OUR ADVANCED HEART DISEASE PATIENTS. STUDY TITLE: HOME ECG MONITORING TO DETECT ALLOGRAFT REJECTION FOLLOWING HEART TRANSPLANTATION SPONSOR: NIH/UNIVERSITY OF CALIFORNIA, SAN FRANCISCO PROJECT SUMMARY: THE BROAD, LONG-TERM GOAL OF THIS RESEARCH IS TO APPLY NOVEL TECHNOLOGY FOR EARLY DETECTION OF DONOR ORGAN (ALLOGRAFT) REJECTION TO IMPROVE PATIENT OUTCOMES FOLLOWING HEART TRANSPLANTATION. THE SPECIFIC GOAL OF THIS INITIAL STUDY IS TO DETERMINE WHETHER DAILY MONITORING OF THE TRANSPLANT RECIPIENT'S ELECTROCARDIOGRAM (ECG) USING A SIMPLE HOME DEVICE WITH TELEPHONE TRANSMISSION TO AN ECG CORE LABORATORY WOULD PROVIDE AN EARLY SENSITIVE AND SPECIFIC BIOMARKER FOR ACUTE ALLOGRAFT REJECTION. THE SPECIFIC AIMS OF THE STUDY ARE TO: 1) DETERMINE WHETHER AN INCREASE IN THE QT INTERVAL DURING THE FIRST 6 MONTHS FOLLOWING HEART TRANSPLANT IS A SENSITIVE AND SPECIFIC BIOMARKER FOR BIOPSY-DIAGNOSED ACUTE ALLOGRAFT REJECTION; AND 2) DETERMINE THE TIMING OF INITIAL INCREASED QT INTERVAL RELATIVE TO BIOPSY-DIAGNOSED STAGES OF MILD, MODERATE, AND SEVERE ALLOGRAFT REJECTION. THE SECONDARY AIMS ARE TO: 1) DETERMINE WHETHER AN INCREASE IN THE QT INTERVAL DURING THE FIRST 6 MONTHS FOLLOWING HEART TRANSPLANT PREDICTS ALL-CAUSE OR SUDDEN CARDIAC DEATH MORTALITY WITHIN THE FIRST YEAR; AND 2) EXPLORE ADDITIONAL ECG MEASUREMENTS THAT MIGHT PREDICT ACUTE ALLOGRAFT REJECTION OR DEATH. STUDY TITLE: ENDOTHELIAL CELL REPLACEMENT BY THE HOST AFTER HEART TRANSPLANTATION AND ITS CORRELATION WITH DSA LEVEL AND ALLOGRAFT OUTCOME SPONSOR: TERASAKI FOUNDATION PROJECT SUMMARY: THE PRESENCE OF RECIPIENT DERIVED ENDOTHELIAL CELLS IN THE DONOR ORGAN IS KNOWN AS ENDOTHELIAL CHIMERISM IN TRANSPLANTED ORGANS. SINCE THE 1960S, THERE IS RISING EVIDENCE FOR CELL TRAFFIC FROM THE GRAFT INTO THE HOST AND VICE VERSA FOLLOWING SOLID ORGAN TRANSPLANTATION, AND IT IS BECOMING CLEAR THAT THESE PROCESSES INFLUENCE WHETHER AN ALLOGRAFT IS ACCEPTED OR REJECTED. THE MIGRATION OF RECIPIENT ENDOTHELIAL CELLS INTO TRANSPLANTED ORGANS IS OF SPECIAL INTEREST, AS THIS FORM OF CELL MIGRATION MAY PLAY A KEY ROLE IN ALLOGRAFT ACCEPTANCE. DESPITE THE CLEAR AND WIDELY ACCEPTED NEGATIVE CORRELATION OF DONOR-SPECIFIC ANTIBODIES AND LONG-TERM ALLOGRAFT OUTCOME IN SOLID ORGAN TRANSPLANTATION, THERE ARE STILL A NUMBER OF PATIENTS PRESENTING WITH DONOR SPECIFIC ANTIBODIES THAT DO NOT INTERFERE WITH ALLOGRAFT FUNCTION, EVEN FOR A LONG PERIOD OF TIME. WE HYPOTHESIZE, THAT IN THESE PATIENTS, ENDOTHELIAL CHIMERISM LED TO A TOLERANCE OF THE RECIPIENT IMMUNE SYSTEM TOWARDS THE FOREIGN ORGAN, THEREFORE LEADING TO STABLE ALLOGRAFT FUNCTION DESPITE THE PRESENCE OF DONOR SPECIFIC ANTIBODIES. THIS STUDY WILL TEST FOR ENDOTHELIAL CELL REPLACEMENT IN EXISTING STORED BIOPSY SAMPLES OF PATIENTS ONE YEAR POST HEART TRANSPLANTATION. OUR AIM IS THE EVALUATION OF ENDOTHELIAL CELL CHIMERISM IN CARDIAC ALLOGRAFTS, ITS CORRELATION TO DONOR SPECIFIC ANTIBODY LEVEL AND ITS IMPACT ON ALLOGRAFT OUTCOMES. THE RESULTS MAY HELP TO BETTER UNDERSTAND THE MECHANISMS OF GRAFT ACCEPTANCE AND REJECTION AND THUS MAY HELP IN THE DECISION WHETHER A PATIENT WITH DONOR SPECIFIC ANTIBODIES AFTER ORGAN TRANSPLANTATION NEEDS FURTHER THERAPY OR NOT. |
| FORM 990, PART IV, LINE 12 | THE ORGANIZATION WAS INCLUDED IN A CONSOLIDATED, INDEPENDENT AUDITED FINANCIAL STATEMENTS FOR THE FISCAL YEARS ENDED 6/30/13 AND 6/30/14 DUE TO THE FACT THAT THE TAX YEAR OF ITS TAX-EXEMPT PARENT ORGANIZATION, CEDARS-SINAI MEDICAL CENTER, ENDS ON 6/30. THERE ARE NO AUDITED FINANCIAL STATEMENTS FOR THE YEAR ENDED 12/31/13. |
| FORM 990, PART III, LINE 4A | (CONTINUED) ISCHEMIA STUDY (INTERNATIONAL STUDY OF COMPARATIVE HEALTH EFFECTIVENESS WITH MEDICAL AND INVASIVE APPROACHES) SPONSOR: NIH/NEW YORK SCHOOL OF MEDICINE PROJECT SUMMARY: CORONARY ARTERY DISEASE (CAD) IS THE LEADING CAUSE OF DEATH AND DISABILITY WORLDWIDE AND AFFECTS 17.6 MILLION AMERICANS, RESULTING IN ABOUT 450,000 DEATHS IN THE UNITED STATES ANNUALLY. GLOBALLY, 7.2 MILLION DEATHS ARE CAUSED BY CAD EACH YEAR. AN INVASIVE APPROACH TO THE EVALUATION AND TREATMENT OF CAD IS COMMON, YET EVIDENCE THAT THIS APPROACH TO MANAGEMENT FAVORABLY INFLUENCES LONG-TERM CLINICAL OUTCOMES IN PATIENTS WITH STABLE ISCHEMIC HEART DISEASE (SIHD) IS OUTDATED. OBSERVATIONAL DATA SUGGEST THAT EARLY REVASCULARIZATION IS ASSOCIATED WITH A LOWER LIKELIHOOD OF DEATH AND MYOCARDIAL INFARCTION (MI) IN PATIENTS WITH AT LEAST MODERATE ISCHEMIA ON MYOCARDIAL PERFUSION IMAGING, BUT THIS CONCEPT HAS NEVER BEEN FULLY TESTED IN A PROSPECTIVE, RANDOMIZED CLINICAL TRIAL. PREVIOUS STUDY RESULTS SUPPORT THE HYPOTHESIS THAT THE BENEFIT OF AN INVASIVE STRATEGY IN SIHD PATIENTS IS MOST LIKELY TO BE OBSERVED IN PATIENTS WITH AT LEAST MODERATE ISCHEMIA. IN CONTRAST, A NEWER, UNPUBLISHED ANALYSIS OF OUTCOMES IN THIS COHORT OF PATIENTS SHOWED NO REDUCTION IN DEATH AND MI. MODERATE OR SEVERE ISCHEMIA IS A MARKER FOR INCREASED RISK FOR DEATH, BUT NO WELL-DESIGNED CLINICAL TRIAL OF PATIENTS WITH THIS DEGREE OF ISCHEMIA HAS STUDIED WHETHER AN INVASIVE STRATEGY IMPROVES CLINICAL OUTCOMES AND QUALITY OF LIFE. GIVEN THE POTENTIAL CLINICAL BENEFIT FROM REVASCULARIZATION ON THE ONE HAND, THE SIGNIFICANT EXPENSE OF AN INVASIVE STRATEGY ON THE OTHER, THIS IS A CRITICALLY IMPORTANT ISSUE TO RESOLVE. THE RESULTS OF THE ISCHEMIA STUDY WILL HAVE PROFOUND IMPLICATIONS FOR GUIDELINES, HEALTH POLICY, AND CLINICAL PRACTICE. THIS STUDY AT CSMC PROPOSES TO ENROLL APPROXIMATELY 10 SUBJECTS WITH SIHD. SUBJECTS WILL BE CONSENTED FOLLOWING CLINICALLY-INDICATED STRESS IMAGING. IF THE IMAGES QUALIFY FOR ENROLLMENT, CORONARY COMPUTED TOMOGRAPHY ANGIOGRAPHY (CCTA) WILL BE PERFORMED AND SUBJECTS WILL BE RANDOMIZED TO EITHER THE INVASIVE STRATEGY INVOLVING CATHETERIZATION AND REVASCULARIZATION OR THE OPTIMAL MEDICAL MANAGEMENT STRATEGY. BLOOD WILL ALSO BE DRAWN IN BOTH GROUPS TO ANALYZE BIOMARKERS AND ESTABLISH A GENOMICS BIOREPOSITORY. FOLLOW-UP IN RANDOMIZED SUBJECTS WILL OCCUR AT 1.5, 3, 6, AND 12 MONTHS FOLLOWING RANDOMIZATION DURING THE FIRST YEAR AND EVERY 6 MONTHS THEREAFTER, WITH CLINIC VISITS, PHONE FOLLOW-UP, AND OTHER CLINICALLY-INDICATED TESTING UNTIL THE END OF THE TRIAL. STUDY TITLE: SYNCARDIA FREEDOM DRIVER SYSTEM STUDY SPONSOR: SYNCARDIA SYSTEMS, INC. PROJECT SUMMARY: ON 15 OCTOBER 2004, THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) RECEIVED FDA APPROVAL (PREMARKET APPROVAL APPLICATION [PMA] #P030011) FOR IN-HOSPITAL USE AS A BRIDGE TO TRANSPLANT IN CARDIAC TRANSPLANT-ELIGIBLE CANDIDATES AT RISK OF IMMINENT DEATH FROM BIVENTRICULAR FAILURE. THE IMPLANTABLE TAH-T IS POWERED BY AN EXTERNAL PNEUMATIC DRIVER, THE CIRCULATORY SUPPORT SYSTEM (CSS) CONSOLE. BECAUSE THE SIZE AND WEIGHT OF THE CSS CONSOLE LIMIT THE MOBILITY OF TAH-T PATIENTS, SYNCARDIA DEVELOPED A SMALLER, PORTABLE EXTERNAL PNEUMATIC DRIVER, THE FREEDOM DRIVER SYSTEM, WHICH INCORPORATES SOME OF THE CSS CONSOLE OPERATING PARAMETERS TO PROVIDE THE PNEUMATIC SUPPORT REQUIRED BY THE IMPLANTED TAH-T IN CLINICALLY STABLE PATIENTS, WHILE ENHANCING THEIR MOBILITY. DESIGN VERIFICATION TEST RESULTS DEMONSTRATE THAT THE FREEDOM DRIVER OPERATES WITHIN THE SPECIFICATIONS OF THE CSS CONSOLE TO PROVIDE THE PULSATILE PNEUMATIC PRESSURES REQUIRED TO SUPPORT CLINICALLY STABLE TAH-T PATIENTS SAFELY IN AND OUT OF THE HOSPITAL. THIS CLINICAL STUDY IS INTENDED TO * CONFIRM THE DESIGN VERIFICATION TEST RESULTS THAT DEMONSTRATED THAT THE FREEDOM DRIVER IS A SUITABLE PNEUMATIC DRIVER FOR CLINICALLY STABLE TAH-T PATIENTS AND * CONFIRM THAT PATIENTS AND LAY CAREGIVERS CAN BE TRAINED TO MANAGE THE FREEDOM DRIVER SYSTEM SAFELY OUTSIDE THE HOSPITAL. STUDY TITLE: EXTERNAL FACTORS AND OUTCOMES FOR HEART TRANSPLANT RECIPIENTS: A SINGLE CENTER SURVEY STUDY SPONSOR: INTERNAL PROJECT SUMMARY: CARDIAC TRANSPLANTATION IS CURRENTLY THE PROCEDURE OF CHOICE FOR SELECTED PATIENTS WITH END-STAGE HEART DISEASE THAT IS NOT AMENABLE TO FURTHER MEDICAL INTERVENTION OR CONVENTIONAL CARDIAC PROCEDURES. WITH THE ADVENT OF MORE EFFECTIVE IMMUNOSUPPRESSIVE AGENTS, THE DEFINITION OF THE SUCCESSFULLY MANAGED HEART TRANSPLANT RECIPIENT IS EVOLVING BEYOND THE IMMEDIATE CHALLENGE OF PREVENTING ACUTE REJECTION. THE PURPOSE OF THIS SURVEY STUDY IS TO ASSESS A VARIETY OF FACTORS AND THEIR IMPACT ON BOTH SHORT-TERM AND LONG-TERM OUTCOMES AND QUALITY OF LIFE POST HEART TRANSPLANTATION. DATA TO BE COLLECTED WILL INCLUDE DEMOGRAPHIC DATA, PSYCHOSOCIAL DATA AND PHYSICAL DATA. TO DATE 552 PATIENTS HAVE COMPLETED THE SURVEY. STUDY TITLE: PROSPECTIVE, MULTI-CENTER, RANDOMIZED CLINICAL INVESTIGATION OF TRANSMEDICS ORGAN CARE SYSTEM (OCS) FOR CARDIAC USE SPONSOR: TRANSMEDICS PROJECT SUMMARY: THE TRANSMEDICS ORGAN CARE SYSTEM IS A PORTABLE ORGAN PERFUSION AND MONITORING SYSTEM INTENDED TO PRESERVE A DONATED HEART IN A BEATING STATE DURING TRANSPORT FOR THE EVENTUAL TRANSPLANTATION INTO A RECIPIENT. THE ORGAN CARE SYSTEM (OCS) MAINTAINS ORGAN VIABILITY BY PROVIDING A CONTROLLED ENVIRONMENT, CONTINUOUSLY PERFUSING THE DONATED HEART WITH WARM, OXYGENATED BLOOD, SUPPLEMENTED WITH THE TRANSMEDICS CARDIAC SOLUTION SET. THE BLOOD IS COLLECTED FROM THE DONOR AND IS CONTINUOUSLY CIRCULATED TO THE ORGAN IN A CLOSED CIRCUIT ALONG WITH THE CARDIAC SOLUTION SET. THE OCS PRESERVES THE HEART AND MONITORS THE ORGAN'S PERFUSION PARAMETERS IMMEDIATELY AFTER EXPLANTATION FROM A DONOR AND CONNECTION TO THE DEVICE, DURING TRANSPORTATION TO THE RECIPIENT SITE, AND UNTIL DISCONNECTION FROM THE DEVICE. THE PURPOSE OF THIS STUDY IS TO COMPARE THE SAFETY AND EFFECTIVENESS OF THE OCS WITH THE EXISTING COLD STATIC CARDIOPLEGIA STANDARD OF CARE FOR THE PRESERVATION OF DONOR HEARTS. CSMC ENROLLED 39 SUBJECTS IN THIS STUDY, WITH ALL FOLLOW-UP COMPLETE. STUDY TITLE: THE MEDICAL ARM OF MECHANICAL CIRCULATORY SUPPORT (MEDAMACS) STUDY SPONSOR: NIH/UNIVERSITY OF ALABAMA PROJECT SUMMARY: DESPITE WIDESPREAD USE OF EVIDENCE-BASED MEDICAL THERAPIES, MORTALITY AND MORBIDITY FROM SYSTOLIC HEART FAILURE REMAIN HIGH. BREAKTHROUGHS IN THE MECHANIC CIRCULATORY SUPPORT TECHNOLOGY HAVE EXTENDED SURVIVAL AND IMPROVED QUALITY IN ADVANCED HEART FAILURE PATIENTS AWAITING CARDIAC TRANSPLANTATION AND IN INOTROPE-DEPENDENT PATIENTS WHO ARE ELIGIBLE FOR HEART TRANSPLANT. THE INTERMACS REGISTRY HAS FACILITATED THE REFINEMENT OF PATIENT SELECTION FOR THIS THERAPY BY ANALYSIS OF THOSE PATIENTS WHO HAVE RECEIVED DEVICES. INTEGRAL TO THE ORIGINAL INTENT OF INTERMACS WAS COMPARISON TO AMBULATORY PATIENTS LIVING WITH ADVANCED HEART FAILURE WHO WERE NOT CURRENTLY RECEIVING MECHANICAL CIRCULATORY SUPPORT DEVICES. MEDAMACS WILL CHARACTERIZE THE TYPES OF PATIENTS WHO ARE NOT RECEIVING AN LVAD CURRENTLY DUE TO THE INTERSECTION OF RELATIVE CONTRAINDICATIONS, TO THEIR OWN PREFERENCES, OR TO THEIR CHARACTERIZATION AS "LESS SICK" EITHER BY PERCEPTION OR BY ABSOLUTE CRITERIA AS CURRENTLY DEFINED FOR LIFETIME VAD SUPPORT. THIS WILL BE A PROSPECTIVE, OBSERVATIONAL STUDY OF AMBULATORY PATIENTS WITH ADVANCED HEART FAILURE. STUDY ACTIVITIES INCLUDE BASELINE A (AT CONSENT), BASELINE B (3-6 WEEKS FOLLOWING CONSENT), 6 MONTH TELEPHONE CALL, 12 MONTH FOLLOW-UP, 18 MONTH TELEPHONE CALL, AND 24 MONTH FOLLOW-UP. RESEARCHERS WILL COLLECT DATA FROM 6 MINUTE WALK TESTS, MEDICAL RECORDS, AND QUESTIONNAIRES/SURVEYS. |
| FORM 990, PART III, LINE 4A | (CONTINUED) STUDY TITLE: THE DE-NOVO USE OF ECULIZUMAB ALONGSIDE CONVENTIONAL THERAPY THERAPY IN PRESENSITIZED PATIENTS RECEIVING CARDIAC TRANSPLANTATION: AN OPEN-LABEL, INVESTIGATOR-INITIATED PILOT TRIAL: [THE DUET CARDIAC TRIAL] SPONSOR: ALEXION PHARMACEUTICALS PROJECT SUMMARY: THE GROWING PROPORTION OF SENSITIZED CARDIAC RECIPIENTS PRESENTS AN ADDITIONAL CHALLENGE TO THE TRANSPLANT PRACTITIONER ATTEMPTING TO MINIMIZE THE OCCURRENCE OF ANTIBODY MEDIATED REJECTION (AMR). PATIENTS PRE-EXPOSED OR "SENSITIZED" TO ANTIGEN EXPOSING EVENTS (I.E.: BLOOD TRANSFUSIONS, MULTIPLE PREGNANCIES, PRIOR ORGAN TRANSPLANTATIONS, VENTRICULAR SUPPORT DEVICES) ARE MORE LIKELY TO BOTH POSSESS PREFORMED AND DEVELOP DE-NOVO ANTIBODIES. SENSITIZED PATIENTS WITH PANEL REACTIVE ANTIBODIES > 25% ARE AT RISK FOR INCREASED MORTALITY AFTER HEART TRANSPLANTATION. A CENTRAL COMPONENT OF ANTIBODY-MEDIATED CELL INJURY IS COMPLEMENT ACTIVATION. THE INHIBITION OF TERMINAL COMPLEMENT ACTIVATION MAY BE THE MISSING LINK TO DECREASING POSSIBLY BOTH COMPLEMENT-MEDIATED AMR AND CELLULAR REJECTION (CR) BY INHIBITING BOTH THE INFLAMMATORY EFFECTS OF BOTH CIRCULATING ANTIBODIES AND CYTOKINE INDUCED CELL DEATH. ECULIZUMAB IS A MONOCLONAL ANTIBODY THAT SPECIFICALLY BINDS TO COMPLEMENT PROTEIN C5 WITH HIGH AFFINITY, THEREBY INHIBITING ITS CLEAVAGE TO C5A AND C5B AND PREVENTING THE GENERATION OF THE TERMINAL COMPLEMENT COMPLEX C5B-9. BY THIS MECHANISM, ECULIZUMAB (SOLIRIS) INHIBITS TERMINAL COMPLEMENT MEDIATED INTRAVASCULAR HEMOLYSIS IN PAROXYSMAL NOCTURNAL HEMOGLOBINURIA PATIENTS. THIS STUDY IS A NON-RANDOMIZED, OPEN-LABEL, INVESTIGATOR-INITIATED SAFETY AND EFFICACY TRIAL INVESTIGATING THE DE-NOVO USE OF ECULIZUMAB ALONGSIDE CONVENTIONAL THERAPY TO PREVENT ANTIBODY MEDIATED REJECTION. THE DURATION OF THE STUDY WILL INCLUDE AN OPEN ENROLLMENT PERIOD AND AT LEAST 12 MONTHS OF FOLLOW-UP (POST-TRANSPLANT). THE TRIAL WILL ENROLL A TOTAL OF UP TO 10 "SENSITIZED" PATIENTS WITH A PANEL REACTIVE ANTIBODY SCORE OF GREATER THAN 70% AND NOT PREVIOUSLY OR CURRENTLY ENROLLED IN ANOTHER ONGOING TRIAL. AT THE TIME OF INITIAL BASELINE SCREENING PRIOR TO TRANSPLANTATION, PATIENTS WILLING TO CONSENT TO THE INVESTIGATIONAL USE OF ECULIZUMAB WILL BE ENROLLED IN THE TREATMENT ARM (COMPRISING A MAXIMUM OF 10 PATIENTS). THE USE OF ECULIZUMAB WILL BE UN-BLINDED TO ALL STUDY AND RESEARCH PRACTITIONER PARTICIPANTS. A HISTORICAL COHORT OF 10 ADDITIONAL PATIENTS WILL ALSO BE UTILIZED FOR COMPARISON. |
| FORM 990, PART VI, SECTION A, LINE 2 | LAURENCE MARTON, MD, DIRECTOR AND ERIC MARTON, PRESIDENT HAVE A FAMILY RELATIONSHIP. |
| FORM 990, PART VI, SECTION A, LINE 6 | CEDARS-SINAI MEDICAL CENTER IS THE SOLE CORPORATE MEMBER OF CALIFORNIA HEART CENTER FOUNDATION. |
| FORM 990, PART VI, SECTION A, LINE 7A | CEDARS-SINAI MEDICAL CENTER AS THE SOLE CORPORATE MEMBER, CAN ELECT BOARD OF DIRECTORS TO CALIFORNIA HEART CENTER FOUNDATION. |
| FORM 990, PART VI, SECTION A, LINE 7B | RESERVED RIGHTS OF CEDARS-SINAI MEDICAL CENTER, THE SOLE CORPORATE MEMBER OF THE ORGANIZATION. THE FOLLOWING ACTIONS MUST BE APPROVED OR ACTED UPON BY CEDARS-SINAI MEDICAL CENTER BEFORE BECOMING EFFECTIVE: (A) ANY SALE OR OTHER DISPOSITION OF ALL OR A SUBSTANTIAL PORTION OF THE ASSETS OF THE ORGANIZATION; (B) ANY MERGER OR AFFILIATION OF THE ORGANIZATION WITH ANY PERSON OR ENTITY OTHER THAN THE MEMBER; (C) ANY AMENDMENT TO THE ARTICLES OF INCORPORATION OR BYLAWS OF THE ORGANIZATION; (D) ANY ACT OR OMISSION WHICH CREATES ANY MATERIAL RISK TO THE MEMBER'S TAX EXEMPT STATUS, OR CREATES ANY MATERIAL RISK OF A VIOLATION OF ANY STATE OR FEDERAL LAWS; (E) DISSOLUTION OF THE ORGANIZATION OR THE FILING OF ANY BANKRUPTCY PETITION; (F) CREATION OF ANY NEW CORPORATION, PARTNERSHIP OR ASSOCIATION; (G) ACQUISITION OF OR THE INVESTMENT IN A NEW OPERATING BUSINESS; (H) ENTERING INTO ANY PARTNERSHIPS OR JOINT VENTURES; (I) ADOPTION OF OR CHANGES TO OPERATING OR CAPITAL BUDGETS; (J) ADOPTION OF THIS CORPORATION'S POLICIES AND PROCEDURES; (K) EXECUTION AND DELIVERY OF ANY NEW AFFILIATION AGREEMENTS AND OTHER RELATIONSHIPS WITH THE UCLA SCHOOL OF MEDICINE AND OTHER INSTITUTIONS OF MEDICAL LEARNING; (L) UNBUDGETED CAPITAL EXPENDITURES OVER $100,000; (M) LOANS, BORROWINGS OR GUARANTEES IN EXCESS OF $100,000, UNLESS APPROVED IN THE BUDGET; (N) ANY SECURITY INTERESTS OR MORTGAGES ON THE PROPERTY OF ORGANIZATION; (O) OPERATING OR CAPITAL LEASES WHERE THE TERM IS OVER FIVE YEARS OR THE TOTAL OBLIGATION UNDER THE LEASE EXCEEDS $100,000, UNLESS APPROVED IN THE BUDGET; (P) TERMINATION OR SELECTION OF THE AUDITORS OF THE ORGANIZATION; (Q) SUBJECT TO SECTION 5.08, APPOINTMENT OR REMOVAL OF ANY MEMBER OF THE BOARD (OTHER THAN EX-OFFICIO DIRECTORS); (R) APPOINTMENT OF REMOVAL OF ANY OFFICERS; (S) EXECUTION AND DELIVERY OF ANY PROFESSIONAL SERVICE AGREEMENTS; (T) RELOCATION OF PRINCIPAL OFFICE; (U) FIXING THE NUMBER OF DIRECTORS OF THE ORGANIZATION |
| FORM 990, PART VI, SECTION B, LINE 11 | THE ORGANIZATION'S FORM 990 UNDERGOES AN INTENSE AND HIGHLY COMPREHENSIVE REVIEW PROCESS. THE REVIEW INVOLVES VARIOUS MANAGEMENT PERSONNEL AND A BIG FOUR ACCOUNTING FIRM. |
| FORM 990, PART VI, SECTION B, LINE 12C | CONFLICT OF INTEREST POLICY ANNUAL STATEMENTS: EACH DIRECTOR, OFFICER, MEMBER OF A COMMITTEE WITH BOARD-DELEGATED POWERS AND ANY OTHER INTERESTED PERSON AS DETERMINED BY THE BOARD OR COMMITTEE SHALL AT LEAST ANNUALLY SIGN A COPY OF THE "STATEMENT PERTAINING TO CONFLICT OF INTEREST." IF A DIRECTOR, OFFICER, OR COMMITTEE MEMBER, OR DESIGNATED INTERESTED PERSON BECOMES AWARE THAT A POTENTIAL OR APPARENT CONFLICT MAY EXIST WHICH IS NOT DISCLOSED ON SUCH A STATEMENT, IT SHALL BE THE RESPONSIBILITY OF THE INTERESTED PERSON TO DISCLOSE THE POTENTIAL CONFLICT TO THE PRESIDENT AND TO THE BOARD OR APPROPRIATE COMMITTEE AND AS SET FORTH ABOVE, PRIOR TO ANY BOARD OR COMMITTEE DISCUSSIONS OR ACTION WITH RESPECT TO THE RELEVANT TRANSACTION OR ARRANGEMENT, AND, IF RELEVANT, TO LEAVE THE MEETING DURING THE DISCUSSION AND VOTE ON THE TRANSACTION OR ARRANGEMENT. DETERMINING WHETHER A CONFLICT OF INTEREST EXISTS: IF CONSIDERATION OF THE TRANSACTION OR ARRANGEMENT AT ISSUE IS A MATTER WITHIN THE SCOPE OF AUTHORITY OF THE BOARD OF DIRECTORS OR A COMMITTEE, AFTER DISCLOSURE OF THE FINANCIAL INTEREST AND AFTER ANY DISCUSSION WITH THE INTERESTED PERSON, THE RELEVANT CALIFORNIA HEART CENTER FOUNDATION ("CHCF") OFFICER OR ADMINISTRATOR SHALL DETERMINE WHETHER A CONFLICT OF INTEREST EXISTS. IF IT IS DETERMINED THAT A CONFLICT OF INTEREST EXISTS AND, NOTWITHSTANDING THE CONFLICT, THE CHCF OFFICER OR ADMINISTRATOR DETERMINES THAT IT CONTINUES TO BE IN THE BEST INTERESTS OF CHCF TO PROCEED WITH THE TRANSACTION OR ARRANGEMENT AT ISSUE, THE CHCF OFFICER OR ADMINISTRATOR SHALL REFER THE TRANSACTION OR ARRANGEMENT TO THE BOARD OR THE APPROPRIATE BOARD-DESIGNATED COMMITTEE FOR EVALUATION. ALTERNATIVELY IF CONSIDERATION OF THE TRANSACTION OR ARRANGEMENT AT ISSUE IS A MATTER WITHIN THE SCOPE OF THE AUTHORITY OF THE BOARD OF DIRECTORS OR A COMMITTEE, THE INTERESTED PERSON SHALL LEAVE THE BOARD OR COMMITTEE MEETING WHILE THE DETERMINATION OF THE EXISTENCE OF A CONFLICT OF INTEREST IS DISCUSSED AND VOTED UPON. THE REMAINING BOARD OR COMMITTEE MEMBERS SHALL DECIDE, BY MAJORITY VOTE, IF A CONFLICT OF INTEREST EXISTS. PROCEDURES FOR ADDRESSING THE CONFLICT OF INTEREST: A. AN INTERESTED PERSON MAY MAKE A PRESENTATION TO THE BOARD OR COMMITTEE REGARDING THE TRANSACTION OR ARRANGEMENT. AFTER SUCH PRESENTATION THE INTERESTED PERSON MUST LEAVE THE MEETING DURING THE DISCUSSION OF, AND THE VOTE ON THE TRANSACTION OR ARRANGEMENT. B. THE CHAIR OF THE BOARD OR COMMITTEE SHALL, IF DEEMED APPROPRIATE BY THE BOARD OR COMMITTEE, APPOINT A DISINTERESTED PERSON OR COMMITTEE TO INVESTIGATE ALTERNATIVES TO THE PROPOSED TRANSACTION OR ARRANGEMENT. C. AFTER EXERCISING DUE DILIGENCE, THE BOARD OR COMMITTEE SHALL DETERMINE WHETHER CHCF CAN OBTAIN A MORE ADVANTAGEOUS TRANSACTION OR ARRANGEMENT WITH REASONABLE EFFORTS FROM A PERSON OR ENTITY THAT WOULD NOT GIVE RISE TO A CONFLICT OF INTEREST. D. IF A MORE ADVANTAGEOUS TRANSACTION OR ARRANGEMENT IS NOT REASONABLY ATTAINABLE UNDER CIRCUMSTANCES THAT WOULD NOT GIVE RISE TO A CONFLICT OF INTEREST, THE BOARD OR COMMITTEE SHALL DETERMINE BY A MAJORITY VOTE OF THE DISINTERESTED DIRECTORS WHETHER THE TRANSACTION OR ARRANGEMENT IS IN CHCF' BEST INTEREST AND FOR ITS OWN BENEFIT AND WHETHER THE TRANSACTION IS FAIR AND REASONABLE TO CHCF AND SHALL MAKE ITS DECISION AS TO WHETHER TO ENTER INTO THE TRANSACTION OR ARRANGEMENT IN CONFORMITY WITH SUCH DETERMINATION. VIOLATIONS OF THE CONFLICTS POLICY: A. IF THE BOARD OR COMMITTEE HAS REASONABLE CAUSE TO BELIEVE THAT A MEMBER OF THE BOARD OR COMMITTEE OR AN OFFICER OR OTHER INTERESTED PERSON HAS FAILED TO DISCLOSE AN ACTUAL OR POSSIBLE CONFLICT OF INTEREST, IT SHALL INFORM THE MEMBER OR OFFICER OR INTERESTED PERSON OF THE BASIS FOR SUCH BELIEF AND AFFORD SUCH PERSON AN OPPORTUNITY TO EXPLAIN THE ALLEGED FAILURE TO DISCLOSE. B. IF, AFTER HEARING THE RESPONSE OF SUCH PERSON AND MAKING SUCH FURTHER INVESTIGATION AS MAY BE WARRANTED IN THE CIRCUMSTANCES, THE BOARD OR COMMITTEE DETERMINES THAT SUCH PERSON HAS IN FACT FAILED TO DISCLOSE AN ACTUAL OR POSSIBLE CONFLICT OF INTEREST, IT SHALL TAKE APPROPRIATE DISCIPLINARY AND CORRECTIVE ACTION. |
| FORM 990, PART VI, SECTION B, LINE 15B | THE EXECUTIVE PERSONNEL COMMITTEE (THE COMMITTEE) OF THE TAX-EXEMPT PARENT OF THE ORGANIZATION, CEDARS-SINAI MEDICAL CENTER, IS A STANDING COMMITTEE OF THE BOARD OF DIRECTORS. THE COMMITTEE ADDRESSES COMPENSATION AND BENEFITS REGARDING THE ORGANIZATION'S CHIEF FINANCIAL OFFICER AND BOARD MEMBERS WHO ARE ALSO EXECUTIVE EMPLOYEES AND CONTRACTUALLY ENGAGED FACULTY OF THE MEDICAL CENTER, AND IS AUTHORIZED BY THE BOARD OF DIRECTORS TO ACT ON BEHALF OF THE BOARD WITH RESPECT TO SUCH ISSUES, AND OTHER GOVERNANCE ISSUES AS REQUESTED BY THE BOARD OF DIRECTORS, THE EXECUTIVE COMMITTEE OF THE BOARD OF DIRECTORS, THE CHAIR OF THE BOARD OF DIRECTORS, OR THE CEO, ALL SUBJECT TO THE COMMITTEE'S ONGOING REPORTING OBLIGATION TO THE BOARD OF DIRECTORS OR THE EXECUTIVE COMMITTEE OF THE BOARD OF DIRECTORS. SPECIFICALLY, THE COMMITTEE EVALUATES THE PERFORMANCE AND APPROVES THE COMPENSATION AND BENEFITS FOR THE ORGANIZATION'S CHIEF FINANCIAL OFFICER AND BOARD MEMBERS WHO ARE ALSO EXECUTIVE EMPLOYEES AND CONTRACTUALLY ENGAGED FACULTY OF THE MEDICAL CENTER. THE MEMBERS OF THE COMMITTEE ARE APPOINTED ANNUALLY BY THE CHAIR OF THE MEDICAL CENTER'S BOARD OF DIRECTORS. APPOINTMENTS ARE FOR A ONE YEAR TERM. EACH YEAR, THE COMMITTEE FOLLOWS A PROCESS THAT ENSURES THAT THE COMPENSATION AND BENEFITS IS REASONABLE AND IN COMPLIANCE WITH APPLICABLE LAWS AND REGULATIONS. THE MEDICAL CENTER'S SVP OF HR PROVIDES STAFF SUPPORT TO THE COMMITTEE. THE COMMITTEE MAY INCLUDE MEMBERS OF THE MEDICAL CENTER'S MANAGEMENT TEAM OR ANY OTHER PERSON WHOSE PRESENCE THE COMMITTEE BELIEVES TO BE DESIRABLE OR APPROPRIATE. THE COMMITTEE MAY ENGAGE AN INDEPENDENT COMPENSATION AND BENEFITS CONSULTANT AND ANY OTHER ADVISORS THEY DEEM NECESSARY. THE COMMITTEE MAY ALSO ENGAGE INDEPENDENT COUNSEL. THE MEDICAL CENTER WILL PROVIDE FOR APPROPRIATE FUNDING FOR PAYMENT OF COSTS TO ANY SUCH PERSONS RETAINED BY THE COMMITTEE. ANNUALLY, AT THE COMMITTEE'S DIRECTION, THE INDEPENDENT COMPENSATION CONSULTANT SHALL PREPARE SUCH REPORTS AS THE COMMITTEE REASONABLY DEEMS NECESSARY. AT A MINIMUM, SUCH REPORTS WILL INCLUDE MARKET SURVEY DATA FROM A PEER GROUP DESIGNATED BY THE COMMITTEE, WHICH SHALL BE CONSIDERED BY THE COMMITTEE PRIOR TO MAKING DECISIONS. THE COMMITTEE MEETS AS FREQUENTLY AS THE COMMITTEE DEEMS NECESSARY AND WILL MAINTAIN WRITTEN MINUTES OF ITS MEETING. THE COMPENSATION AND BENEFITS OF THE PRESIDENT AND VICE-PRESIDENT ARE DETERMINED BY THE CHIEF FINANCIAL OFFICER OF THE ORGANIZATION WITH ASSISTANCE FROM HR WHICH PROVIDES AN INDEPENDENT REVIEW OF COMPARABLES. |
| FORM 990, PART VI, SECTION C, LINE 19 | THE ORGANIZATION MAKES ITS GOVERNING DOCUMENTS, ITS CONFLICT OF INTEREST POLICY AND ITS TAX-EXEMPT PARENT'S AUDITED FINANCIAL STATEMENTS AVAILABLE TO THE PUBLIC UPON WRITTEN REQUEST. |
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