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The Portable Organ Care System (OCSâ„¢) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCS Preservation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transplant | Device | To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Survival | Patient survival at 6 months post-transplant. | 6 months post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Utilization Rate | Utilization Rate, defined as the number of eligible DCD donor hearts that met the warm ischemic time limit per protocol and were instrumented on the OCS Heart System that meet the acceptance criteria for transplantation after OCS Heart preservation divided by the total number of eligible DCD donor hearts that met the warm ischemic time limit above and were instrumented on the OCS Heart System. |
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Recipient Inclusion Criteria:
• Primary heart transplant candidates
Recipient Exclusion Criteria:
Prior solid organ or bone marrow transplant
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diago | La Jolla | California | 92037 | United States | ||
| Cedars Sinai |
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| ID | Title | Description |
|---|---|---|
| FG000 | OCS Preservation | Transplant: To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 16, 2020 |
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|
| 24 hours post transplant |
| Los Angeles |
| California |
| 90048 |
| United States |
| Stanford University | Palo Alto | California | 94304 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Evanston | Illinois | 60208 | United States |
| St. Vincent Cardiovascular Research Institute | Indianapolis | Indiana | 46260 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455-0213 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Nyph/Cumc | New York | New York | 10032 | United States |
| Montefiore | The Bronx | New York | 10467 | United States |
| Westchester Medical Center | Valhalla | New York | 10595 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| Sentara | Norfolk | Virginia | 23502 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Froedtert & the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Per Protocol Population |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | OCS Preservation | Transplant: To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Survival | Patient survival at 6 months post-transplant. | Per protocol population reported. Two subjects were withdrawn due to re-transplant and were excluded from the analysis. | Posted | Count of Participants | Participants | 6 months post-transplant |
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| Secondary | Utilization Rate | Utilization Rate, defined as the number of eligible DCD donor hearts that met the warm ischemic time limit per protocol and were instrumented on the OCS Heart System that meet the acceptance criteria for transplantation after OCS Heart preservation divided by the total number of eligible DCD donor hearts that met the warm ischemic time limit above and were instrumented on the OCS Heart System. | 95 eligible DCD donor hearts met the warm ischemic time limit per protocol and were instrumented on the OCS Heart System. | Posted | Count of Units | Hearts Instrumented | 24 hours post transplant | Hearts Instrumented | Hearts Instrumented |
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Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) were captured in this study.
Other [Not Including Serious] Adverse Events were not monitored/assessed, and therefore are not reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OCS Preservation | Transplant: To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation. | 7 | 90 | 53 | 90 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood loss anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Coagulopathy | Blood and lymphatic system disorders | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | Systematic Assessment |
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| Cardiac tamponade | Cardiac disorders | Systematic Assessment |
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| Left ventricular dysfunction | Cardiac disorders | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | Systematic Assessment |
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| Pericardial haemorrhage | Cardiac disorders | Systematic Assessment |
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| Right ventricular dysfunction | Cardiac disorders | Systematic Assessment |
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| Tricuspid valve incompetence | Cardiac disorders | Systematic Assessment |
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| Ventricular fibrillation | Cardiac disorders | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Impaired gastric emptying | Gastrointestinal disorders | Systematic Assessment |
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| Intestinal ischaemia | Gastrointestinal disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Transplant rejection | Immune system disorders | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | Systematic Assessment |
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| Fungaemia | Infections and infestations | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Mental status changes postoperative | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypernatraemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
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| Vocal cord paralysis | Nervous system disorders | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Haemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
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| Haematoma | Vascular disorders | Systematic Assessment |
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| Haemorrhage | Vascular disorders | Systematic Assessment |
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| Peripheral ischaemia | Vascular disorders | Systematic Assessment |
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Site shall have right to publish results. To balance this right with TransMedics' (TM) proprietary interests, site will submit manuscripts intended for publication for TM's review at least 30 days prior to submission date. TM will complete its review within 30 days of receipt. TM may request that site delete from its manuscripts any reference to TM confidential information and site shall promptly comply with such request.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Damme, VP Clinical Affairs | TransMedics Inc. | 9785520900 | ldamme@transmedics.com |
| Apr 5, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014180 | Transplantation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Hearts Instrumented |
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