Enhancing Heart Allograft Function With the OCS Heart System Trial (ENHANCE)

TransMedics

Status: Enrolling

Conditions: Heart Transplant

Treatments: Device: OCS Heart; Other: Static Cold Storage (SCS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07145515

OCS-HEART-031725

Details and patient eligibility

About

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.

Enrollment: 655 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Part A - DCD Donor Hearts & DBD Donor Hearts Initially Deemed Unsuitable for Cold Storage (Current Approved Indications):

Donor Inclusion Criteria

• 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%

Donor Exclusion • Moderate to severe aortic incompetence

Part B - DBD Donor Hearts Currently Used with Cold Storage (New Indication):

Donor Inclusion Criteria

• 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.

Donor Exclusion

• Moderate to severe aortic incompetence

• DBD donor with any of the following organ quality concerns:

  • Donor age ≥ 40 years old
  • Unknown downtime
  • Insignificant CAD
  • LVEF ≤ 50%

Recipient Eligibility Criteria (for Part A and B Cohorts)

Inclusion

• Signed informed consent document and authorization to use and disclose protected health information
• Heart transplant candidate
• Age ≥ 18 years old

Exclusion

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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655 participants in 3 patient groups

Part A (OCS Heart)

Experimental group

Description:

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

Treatment:

Device: OCS Heart

Part B (OCS Heart)

Experimental group

Description:

DBD Donor Hearts Currently Used with Cold Storage

Treatment:

Device: OCS Heart

Part B (SCS)

Active Comparator group

Description:

DBD Donor Hearts Currently Used with Cold Storage

Treatment:

Other: Static Cold Storage (SCS)