Enhancing Heart Allograft Function With the OCS Heart System Trial

Part of paid clinical trials in San Francisco, California.

Sponsor
TransMedics
Study ID
NCT07145515
Status
Recruiting
Apply to this trial

Conditions

  • Heart Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OCS Heart — DEVICE
    Preservation of donor hearts with OCS Heart System and novel OCS Solution and OCS Functional Enhancer.
  • Static Cold Storage (SCS) — OTHER
    Preservation of donor hearts with static cold storage.

Study Details

This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation. In addition, this trial will evaluate the performance of the novel OCS Solution and OFE compared to Static Cold Storage (SCS) in DBD heart transplantation to potentially demonstrate superiority.

Key Dates

Start date
Jan 31, 2026
Status verified
Jan 2026
Primary completion
Jan 30, 2027
Completion
Jul 30, 2027

Study Design

Enrollment
655 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A (OCS Heart)
    DCD Donor Hearts \& DBD Donor Hearts Initially Deemed Unsuitable for Cold Storage (Current Approved Indications)
  • Experimental: Part B (OCS Heart)
    DBD Donor Hearts Currently Used with Cold Storage
  • Active Comparator: Part B (SCS)
    DBD Donor Hearts Currently Used with Cold Storage

Primary Outcome Measure

Patient and graft survival [ Time Frame: 30-day post transplant ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143
Liviu Klein, MD (PRINCIPAL_INVESTIGATOR)
Tampa General HospitalTampaFlorida33606
Courtney Nicholas
[email protected]
813-844-4914
Lucian Lozonschi, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Kamila Drezek
[email protected]
David D'Alessandro, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical Center/ New York Presbyterian HospitalNew YorkNew York10032
Koji Takeda, MD (PRINCIPAL_INVESTIGATOR)
Mount SinaiNew YorkNew York10029
Favio Herbas
[email protected]
Anelechi Anyanwu, MD (PRINCIPAL_INVESTIGATOR)
Westchester Medical CenterValhallaNew York10595
Corazon De La Pena
[email protected]
914-493-2483
David Spielvogel, MD (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27710
Sarah Casalinova
[email protected]
919-613-5621
Jacob Schroder, MD (PRINCIPAL_INVESTIGATOR)
Baylor Scott and WhiteDallasTexas75226
Lesia Parker
Dan Meyer, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By research site
University of California San Francisco· San Francisco, CATampa General Hospital· Tampa, FLMassachusetts General Hospital· Boston, MAColumbia University Irving Medical Center/ New York Presbyterian Hospital· New York, NYMount Sinai· New York, NYWestchester Medical Center· Valhalla, NY

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