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To evaluate the effectiveness of the OCSâ„¢ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCS Preservation | Experimental | OCS Preservation and Assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preservation of Hearts for Transplantation | Device | Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Survival at Day-30 Post Transplant and Absence of Severe Primary Heart Graft Dysfunction in the First 24 Hours Post-transplantation | A composite endpoint of patient survival at Day-30 post-transplant and absence of severe heart primary graft dysfunction (PGD) (left or right ventricle)) in the first 24 hours post-transplantation. | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90211 | United States | ||
| Indiana University |
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| ID | Title | Description |
|---|---|---|
| FG000 | OCS Preservation | OCS Preservation and Assessment Preservation of Hearts for Transplantation: Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OCS Preservation | OCS Heart System: The OCS Heart System preserves the heart in a near-physiological, beating state by perfusing the heart with a warmed, donor-blood based perfusate that is supplemented with nutrients and oxygen in a controlled and protected environment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 at Day-30 Post Transplant and Absence of Severe Primary Heart Graft Dysfunction in the First 24 Hours Post-transplantation | A composite endpoint of patient survival at Day-30 post-transplant and absence of severe heart primary graft dysfunction (PGD) (left or right ventricle)) in the first 24 hours post-transplantation. | Posted | Count of Participants | Participants | 30 Days |
|
|
Per the protocol, all SAEs and heart graft related SAEs will be collected for the first 30 days post-transplant. All-Cause Mortality was assessed for 12 months post-transplant as reported.
Per the protocol, only serious adverse events (SAEs) and Heart Graft-Related SAE's (HGRSAEs) will be captured in this study.
Not Serious AEs were not collected, and therefore 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 | OCS Preservation and Assessment Preservation of Hearts for Transplantation: Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Damme | TransMedics Inc. | 9785520900 | ldamme@transmedics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2017 | Dec 23, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 21, 2018 | Dec 23, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014180 | Transplantation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | United States |
| University of Michigan | Ann Arbor | Michigan | United States |
| Spectrum Health | Grand Rapids | Michigan | United States |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | United States |
| University of Minnesota Medical Center | Minneapolis | Minnesota | United States |
| Mount Sinai | New York | New York | 10029 | United States |
| Duke University Medical Center | Durham | North Carolina | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | United States |
| University of Washington Medical Center | Seattle | Washington | 98105 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| 12 |
| 75 |
| 56 |
| 75 |
| 0 |
| 0 |
| Arrhythmia supraventricular | Cardiac disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | Systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
|
| Cor pulmonale | Cardiac disorders | Systematic Assessment |
|
| Electromechanical dissociation | Cardiac disorders | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | Systematic Assessment |
|
| Left ventricular failure | Cardiac disorders | Systematic Assessment |
|
| Nodal rhythm | Cardiac disorders | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
|
| Right ventricular dysfunction | Cardiac disorders | Systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | Systematic Assessment |
|
| Atrial septal defect | Congenital, familial and genetic disorders | Systematic Assessment |
|
| Multi-organ failure | General disorders | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | Systematic Assessment |
|
| Heart transplant rejection | Immune system disorders | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | Systematic Assessment |
|
| H1N1 influenza | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
|
| Cardiac procedure complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Heart injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Operative haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Postoperative thoracic procedure complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Rectal laceration postoperative | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
|
| Convulsion | Nervous system disorders | Systematic Assessment |
|
| Vocal cord paralysis | Nervous system disorders | Systematic Assessment |
|
| Delirium | Psychiatric disorders | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hydrothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | Systematic Assessment |
|
| Subclavian vein thrombosis | Vascular disorders | Systematic Assessment |
|
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