Trial record 3 of 3 for:
Bryan Whitson | Ohio, United States
Heart EXPAND Continued Access Protocol
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03835754 |
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Recruitment Status :
Recruiting
First Posted : February 11, 2019
Last Update Posted : January 5, 2021
|
Sponsor:
TransMedics
Information provided by (Responsible Party):
TransMedics
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Brief Summary:
The OCS™ Heart System will be used to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria for transplantation in this continued access protocol.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Transplant | Device: OCS Heart System | Not Applicable |
To provide additional data evaluating the safety and effectiveness of the OCS™ Heart System to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation at a range of transplant centers in the U.S. and to permit patients and physicians access to the OCS Heart System while a PMA application is under preparation and review.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 52 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Heart Expand Continued Access Protocol |
| Actual Study Start Date : | May 1, 2019 |
| Estimated Primary Completion Date : | December 30, 2021 |
| Estimated Study Completion Date : | December 31, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Heart Transplantation
| Arm | Intervention/treatment |
|---|---|
| Experimental: OCS Preservation |
Device: 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 |
Primary Outcome Measures :
- Survival [ Time Frame: 30 days ]Patient survival post transplant
- Absence of severe PGD [ Time Frame: 24 hours post heart transplant ]Absence of severe primary heart graft dysfunction of left and/or right ventricle in the first 24 hours post transplant
Secondary Outcome Measures :
- Survival [ Time Frame: 30 days ]Patient and graft survival
- Incidence of severe PGD [ Time Frame: 24 hours post transplant ]Incidence of severe primary heart graft dysfunction of left and/or right ventricle in the first 24 hours post heart transplant
- Donor heart utilization rate [ Time Frame: 24 hours post-transplant ]The proportion of eligible donor hearts that were successfully transplanted after preservation and assessment on the OCS Heart System
Other Outcome Measures:
- Survival [ Time Frame: 6 and 12 months ]Patient survival at 6 and 12 months post-transplant
- Incidence of primary graft failure [ Time Frame: Through 12 months post transplant ]Incidence of primary graft failure requiring re-transplantation
- ICU stay [ Time Frame: Through hospital discharge, estimated to be 14 days ]Duration of initial post-transplant ICU stay in days
- Hospital stay [ Time Frame: Through hospital discharge, estimated to be 30 days ]Duration of initial post-transplant hospital stay in days
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria (DONOR):
At least one of the following:
- Expected total cross-clamp time of ≥ 4 hours
- Expected total cross-clamp time of ≥ 2 hours PLUS one or more of the following risk factors Donor age 45-55 years, inclusive, with no coronary catheterization data; or Donor age ≥ 55 years; or Left ventricular septal or posterior wall thickness of >12 mm, but ≤ 16 mm; or Reported down time of ≥ 20 min, with stable hemodynamics at time of final assessment; or Left heart ejection fraction (EF) ≥ 40%, but ≤ 50% at time of acceptance of offer; or Donor angiogram with luminal irregularities with no significant CAD (≤ 50%); or History of carbon monoxide poisoning with good cardiac function at time of donor assessment; or Social history of alcoholism with good cardiac function at time of donor assessment; or History of diabetes without significant CAD (≤ 50%) on angiogram.
Exclusion
- CAD with > 50% stenosis on angiogram, or
- Cardiogenic shock or myocardial infarction, or
- EF consistently < 40%, or
- Significant valve disease except for competent bicuspid aortic valve.
Eligibility Criteria (RECIPIENT)
- Registered primary heart transplant candidate
- Age >18 years old
- Written informed consent. Exclusion
- Prior solid organ or bone marrow transplant
- Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal insufficiency requiring dialysis
- Multi-organ transplant.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835754
Contacts
| Contact: Snehal Dhake | +1 978-809-5208 | sdhake@transmedics.com | |
| Contact: Kausar Qidwai | +1 978-494-7105 | kqidwai@transmedics.com |
Locations
| United States, California | |
| Cedars-Sinai | Recruiting |
| Los Angeles, California, United States, 90211 | |
| Contact: Jack Haslett 310-248-7141 jack.haslett@cshs.org | |
| Principal Investigator: Fardad Esmailan, MD | |
| Stanford University | Active, not recruiting |
| Palo Alto, California, United States, 94304 | |
| United States, Connecticut | |
| Yale New Haven Hospital | Active, not recruiting |
| New Haven, Connecticut, United States, 06510 | |
| United States, Florida | |
| AdventHealth Orlando | Recruiting |
| Orlando, Florida, United States, 32803 | |
| Contact: Deanna Allen, RN 407-303-9983 Deanna.Allen@AdventHealth.com | |
| Principal Investigator: Scott Silvestry, MD | |
| United States, Indiana | |
| St. Vincent Cardiovascular Research Institute | Active, not recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Kami Drezek 617-724-2610 kdrezek@mgh.harvard.edu | |
| Principal Investigator: David A D'Alessandro, MD | |
| United States, Minnesota | |
| Minneapolis Heart Institute | Recruiting |
| Minneapolis, Minnesota, United States, 55407 | |
| Contact: Kari Thomas 612-863-7493 kari.m.thomas@allina.com | |
| Principal Investigator: Karol Mudy, MD | |
| United States, New York | |
| Nyph/Cumc | Active, not recruiting |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Sarah Casalinova 919-613-5621 sarah.casalinova@duke.edu | |
| Principal Investigator: Jacob Schroder, MD | |
| United States, Ohio | |
| Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Michael Johnson 614-292-5315 Michael.Johnson2@osumc.edu | |
| Principal Investigator: Bryan Whitson, MD | |
| United States, Tennessee | |
| Vanderbilt Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Lisa Slinger 615-875-2602 lisa.slinger@vumc.org | |
| Principal Investigator: Ashish Shah, MD | |
| United States, Washington | |
| University of Washington Medical Center | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Contact: Carly Mondoy-Loxton 206-221-7197 carlyml@uw.edu | |
| Principal Investigator: Kevin Koomalsingh, MD | |
Sponsors and Collaborators
TransMedics
| Responsible Party: | TransMedics |
| ClinicalTrials.gov Identifier: | NCT03835754 |
| Other Study ID Numbers: |
OCS-CAR-121918 |
| First Posted: | February 11, 2019 Key Record Dates |
| Last Update Posted: | January 5, 2021 |
| Last Verified: | September 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Keywords provided by TransMedics:
|
Heart preservation Beating heart transplant |