Heart EXPAND Continued Access Protocol

Not Applicable

Completed

• Conditions: Heart Transplant
• Interventions: Device: OCS Heart System

• Registration Number: NCT03835754
• Lead Sponsor: TransMedics

Brief Summary

The OCS™ Heart System will be used to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria for transplantation in this continued access protocol.

Detailed Description

To provide additional data evaluating the safety and effectiveness of the OCS™ Heart System to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation at a range of transplant centers in the U.S. and to permit patients and physicians access to the OCS Heart System while a PMA application is under preparation and review.

Study Timeline

• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-11
• Study Start: 2019-04-17
• Primary Completion: 2021-09-15
• Study Completion: 2022-08-12
• Status Verified: 2022-12
• Results First Submitted: 2024-12-23
• Results First Submitted QC: 2024-12-23
• Last Update Submitted: 2024-12-23
• Results First Posted: 2025-01-17
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OCS Preservation	OCS Heart System	-

Primary Outcome Measures

Name	Time	Method
Patient Survival at Day 30 Post-transplantation and Absence of Severe PGD (Left or Right Ventricle) in the First 24 Hours Post-transplantation	30 days	A composite of patient survival at Day 30 and absence of severe primary heart graft dysfunction (PGD) (LV or RV) in the first 24 hours post-transplantation according to ISHLT consensus manuscript in the protocol.

Trial Locations

Locations (12)

Cedars-Sinai; 🇺🇸 Los Angeles, California, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

St. Vincent Cardiovascular Research Institute; 🇺🇸 Indianapolis, Indiana, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States

Minneapolis Heart Institute; 🇺🇸 Minneapolis, Minnesota, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Nyph/Cumc; 🇺🇸 New York, New York, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

Vanderbilt Medical Center; 🇺🇸 Nashville, Tennessee, United States