US National OCS Heart Perfusion (OHP) Registry
Purpose
This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.
Condition
- Heart Transplant
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- N/A
Exclusion Criteria
- N/A
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Other
- Time Perspective
- Other
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| OCS Heart Transplant Recipients | All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry. |
|
Recruiting Locations
Banner University Medical Center Phoenix
Phoenix, Arizona 85006
Phoenix, Arizona 85006
Contact:
Raelyn McGarry
Raelyn McGarry
University of California San Diego
La Jolla, California 92037
La Jolla, California 92037
Lucile Packard Children's Hospital Stanford
Palo Alto, California 94304
Palo Alto, California 94304
Contact:
Tiffany Koyano
Tiffany Koyano
Stanford University
Palo Alto, California 94304
Palo Alto, California 94304
University of California San Francisco
San Francisco, California 94143
San Francisco, California 94143
Boulder
Boulder, Colorado 80309
Boulder, Colorado 80309
Contact:
Nargis Kalia, MPH
Nargis Kalia, MPH
Yale New Haven Hospital
New Haven, Connecticut 06510
New Haven, Connecticut 06510
Mayo Clinic Florida
Jacksonville, Florida 32224
Jacksonville, Florida 32224
Tampa General Hospital
Tampa, Florida 33606
Tampa, Florida 33606
University of Chicago
Chicago, Illinois 60637
Chicago, Illinois 60637
University of Kentucky
Lexington, Kentucky 40506
Lexington, Kentucky 40506
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Minneapolis Heart Institute
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
University of Minnesota
Minneapolis, Minnesota 55414
Minneapolis, Minnesota 55414
Mayo Clinic Rochester
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Columbia University Irving Medical Center/ New York Presbyterian Hospital
New York, New York 10032
New York, New York 10032
Westchester Medical Center
Valhalla, New York 10595
Valhalla, New York 10595
University of North Carolina
Chapel Hill, North Carolina 48109
Chapel Hill, North Carolina 48109
Atrium Health
Charlotte, North Carolina 28203
Charlotte, North Carolina 28203
Duke University
Durham, North Carolina 27710
Durham, North Carolina 27710
The Christ Hospital
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Contact:
William Stewart
William Stewart
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Medical University of South Carolina
Charleston, South Carolina 29425
Charleston, South Carolina 29425
Baylor Scott and White
Dallas, Texas 75226
Dallas, Texas 75226
University of Texas Southwestern
Dallas, Texas 75390
Dallas, Texas 75390
University of Utah
Salt Lake City, Utah 84132
Salt Lake City, Utah 84132
Virginia Commonwealth University Health
Richmond, Virginia 23298
Richmond, Virginia 23298
Contact:
Giorgi Mchedkushvili
Giorgi Mchedkushvili
University of Washington Medical Center
Seattle, Washington 98105
Seattle, Washington 98105
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
More Details
- NCT ID
- NCT05915299
- Status
- Recruiting
- Sponsor
- TransMedics
Detailed Description
The objective of this US National OHP Registry is to collect data on the post-transplant clinical outcomes of all donor hearts preserved and assessed on the OCS Heart System and to document the performance of the OCS Heart device in the real-world setting after FDA approval in the US. The US National OHP Registry will enroll all heart transplant recipients who are transplanted with an OCS-perfused donor heart in the Registry. Patients' clinical outcomes will be followed up to five years post-transplant, loss to follow up, or death, whichever occurs first.