NCT07145515

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
655

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Jan 2026

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Jan 2026Jul 2027

First Submitted

Initial submission to the registry

August 25, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

August 25, 2025

Last Update Submit

January 8, 2026

Conditions

Heart Transplant

Outcome Measures

Primary Outcomes (1)

  • Patient and graft survival

    The primary endpoint is 30-day patient and graft survival with freedom from moderate or severe LV or RV primary graft dysfunction (PGD) in the first 24 hours post-transplant.

    30-day post transplant

Study Arms (3)

Part A (OCS Heart)

EXPERIMENTAL

DCD Donor Hearts \& DBD Donor Hearts Initially Deemed Unsuitable for Cold Storage (Current Approved Indications)

Device: OCS Heart

Part B (OCS Heart)

EXPERIMENTAL

DBD Donor Hearts Currently Used with Cold Storage

Device: OCS Heart

Part B (SCS)

ACTIVE COMPARATOR

DBD Donor Hearts Currently Used with Cold Storage

Other: Static Cold Storage (SCS)

Interventions

OCS HeartDEVICE

Preservation of donor hearts with OCS Heart System and novel OCS Solution and OCS Functional Enhancer.

Part A (OCS Heart)Part B (OCS Heart)
Static Cold Storage (SCS)OTHER

Preservation of donor hearts with static cold storage.

Part B (SCS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and/or on the back table in the donor operating room.
  • All DCD donors eligible for functional warm ischemic time criteria ≤ 30 minutes. WIT defined as time from when mean systolic blood pressure (SBP) is \<50mmHg (sustained for at least 5 minutes) to aortic cross clamp and administration of old cardioplegia in the donor.
  • DBD donor hearts with an expected cross clamp of ≥ 4 hours
  • DBD donor hearts with any of the following organ quality concerns, regardless of cross clamp time:
  • Donor age ≥ 40 years old
  • Unknown downtime
  • Insignificant CAD
  • LVEF ≤ 50%
  • Part B - DBD Donor Hearts Currently Used with Cold Storage (New Indication):
  • Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and/or on the back table in the donor operating room.
  • Eligible for randomization to OCS or SCS treatment arms.
  • DBD donor hearts with an expected cross clamp time of \< 4 hours.
  • Moderate to severe aortic incompetence
  • DBD donor with any of the following organ quality concerns:
  • Donor age ≥ 40 years old
  • +7 more criteria

You may not qualify if:

  • Participant in any other interventional clinical or investigational trials/programs that may confound the outcomes of this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Mount Sinai

New York, New York, 10029, United States

RECRUITING

Columbia University Irving Medical Center/ New York Presbyterian Hospital

New York, New York, 10032, United States

NOT YET RECRUITING

Westchester Medical Center

Valhalla, New York, 10595, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Baylor Scott and White

Dallas, Texas, 75226, United States

RECRUITING

Central Study Contacts

Raicca Haqqi

CONTACT

978-809-0620rhaqqi@transmedics.com

Kausar Qidwai

CONTACT

978-494-7105kqidwai@transmedics.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2025

First Posted

August 28, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

July 30, 2027

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(8)