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OCS Heart Perfusion Post-Approval Registry

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ClinicalTrials.gov Identifier: NCT05047068
Recruitment Status : Recruiting
First Posted : September 16, 2021
Last Update Posted : September 14, 2022
Sponsor:
Information provided by (Responsible Party):
TransMedics

Brief Summary:
The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts.

Condition or disease Intervention/treatment
Transplant Device: OCS Heart System

Detailed Description:

Multi-center, observational post-approval registry to:

  1. compare patient and graft survival of adult primary heart transplant recipients receiving DBD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period, and
  2. compare patient and graft survival of adult primary heart transplant recipients receiving DCD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: OCS Heart Perfusion (OHP) Post-Approval Registry
Actual Study Start Date : September 13, 2021
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2029

Group/Cohort Intervention/treatment
OCS DBD Heart Primary Analysis Population

200 adult primary heart transplant recipients of OCS perfused DBD donor hearts that meet the FDA-approved indication for use except for the following recipient exclusion criteria:

  • Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
  • On renal dialysis at time of transplant
Device: OCS Heart System

The TransMedics® OCS Heart System is a portable system available for ex-vivo maintenance of a donor heart in a metabolically active and beating state.

The OCS Heart System's innovative technology was designed to comprehensively overcome the historical limitations of cold storage. The OCS Heart System expands the utilization of donor hearts by enabling the use of donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of cold static cardioplegic preservation.


OCS DCD Heart Primary Analysis Population

150 adult primary heart transplant recipients of OCS perfused DCD donor hearts that meet the FDA-approved indication for use except for the following recipient exclusion criteria:

  • Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
  • On renal dialysis at time of transplant
  • Transplanted with DCD heart with warm ischemic time > 30 minutes (warm ischemic time is defined as: Time from when mean systolic blood pressure (SBP) is < 50 mmHg or peripheral saturation < 70% to aortic cross-clamp and administration of cold cardioplegia in the donor).
Device: OCS Heart System

The TransMedics® OCS Heart System is a portable system available for ex-vivo maintenance of a donor heart in a metabolically active and beating state.

The OCS Heart System's innovative technology was designed to comprehensively overcome the historical limitations of cold storage. The OCS Heart System expands the utilization of donor hearts by enabling the use of donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of cold static cardioplegic preservation.


Other OCS Heart Analysis Population
Any/all other recipients of OCS Heart perfused donor hearts outside of the DBD and DCD indications above will be collected in the respective arm of this registry until the enrollment of the PAP of that arm is completed (200 for DBD and 150 for DCD).
Device: OCS Heart System

The TransMedics® OCS Heart System is a portable system available for ex-vivo maintenance of a donor heart in a metabolically active and beating state.

The OCS Heart System's innovative technology was designed to comprehensively overcome the historical limitations of cold storage. The OCS Heart System expands the utilization of donor hearts by enabling the use of donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of cold static cardioplegic preservation.





Primary Outcome Measures :
  1. Patient Survival [ Time Frame: One year post-heart transplant ]
    Patient survival at one-year post-heart transplant.


Other Outcome Measures:
  1. Safety Endpoint [ Time Frame: 6 months post-heart transplant ]
    Heart graft survival at 6 months post-heart transplant.

  2. Long Term Patient Survival [ Time Frame: 5 years post-heart transplant ]
    K-M Patient survival at 1, 2, 3, 4 and 5 years post-transplant

  3. Long Term Graft Survival [ Time Frame: 5 years post-heart transplant ]
    K-M Graft survival at 6mo, 1, 2, 3, 4 and 5 years post-transplant



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be adult primary heart transplant potential recipients on the waiting list for heart transplantation at the participating Registry centers.
Criteria

Inclusion Criteria:

  • Adult primary heart transplant recipients of DBD or DCD donor hearts perfused on the OCS Heart System.

Recipient Exclusion Criteria:

  • Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
  • On renal dialysis at time of transplant.

Donor Exclusion Criteria (for DCD Donor Hearts only):

  • Warm ischemic time > 30 minutes (warm ischemic time is defined as: Time from when mean systolic blood pressure (SBP) is < 50 mmHg or peripheral saturation < 70% to aortic cross-clamp and administration of cold cardioplegia in the donor).

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): NCT05047068


Contacts
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Contact: Raicca Haqqi 9788090620 rhaqqi@transmedics.com
Contact: Kausar Qidwai 9785520984 kqidwai@transmedics.com

Locations
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United States, California
Cedars Sinai Recruiting
Los Angeles, California, United States, 90048
Contact: Jack Haslett    310-248-7141    jack.haslett@cshs.org   
Principal Investigator: Fardad Esmailian, MD         
United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Heidi Stevens       stevens.heidi1@mayo.edu   
Contact: Mauricia Buchanan       Buchanan.Mauricia@mayo.edu   
Principal Investigator: Si Pham, MD         
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Courtney Nicholas    813-844-4914    courtneynicholas@tgh.org   
Principal Investigator: John Dunning, MD         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Rivka Elbein    404-712-4117    rselbei@emory.edu   
Principal Investigator: Mani Daneshmand, MD         
United States, Illinois
Northwestern Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Anna Huskin    312-695-4067    Anna.huskin@nm.org   
Principal Investigator: Duc Thinh Pham, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Didjana Celkupa       dcelkupa@tuftsmedicalcenter.org   
Principal Investigator: Gregory Couper, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kamila Drezek    617-724-2610    KDREZEK@mgh.harvard.edu   
Principal Investigator: David D'Alessandro, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kristina Sidopoulos       ksidopoulos@bwh.harvard.edu   
Principal Investigator: Hari R Mallidi, 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
Montefiore Recruiting
Bronx, New York, United States, 10467
Contact: Magdalena Mamczur-Madry, RN, BSN, MS    718-920-3576    mmamczur@montefiore.org   
Principal Investigator: Daniel Goldstein, MD         
Nyph/Cumc Recruiting
New York, New York, United States, 10032
Contact: Bo Lu       bl2699@cumc.columbia.edu   
Principal Investigator: Koji Takeda, MD         
Westchester Medical Center Recruiting
Valhalla, New York, United States, 10595
Contact: Corazon DeLaPena       Corazon.DeLaPena@wmchealth.org   
Principal Investigator: Masashi Kai, MD         
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, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Lisa Slinger    615-875-2602    lisa.slinger@vanderbilt.edu   
Principal Investigator: Ashish Shah, MD         
United States, Texas
Methodist Hospital Recruiting
San Antonio, Texas, United States, 78229
Contact: Paige Castaneda         
Principal Investigator: Masahiro Ono, MD. PhD.         
United States, Wisconsin
Froedtert & the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Kelly Potzner       kpotzner@mcw.edu   
Principal Investigator: David Joyce, MD         
Sponsors and Collaborators
TransMedics
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Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT05047068    
Other Study ID Numbers: OCSHEART-01-ClinPAS
First Posted: September 16, 2021    Key Record Dates
Last Update Posted: September 14, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes