International EXPAND Heart Pivotal Trial (EXPANDHeart)

TransMedics

Status: Completed

Conditions: Heart Transplant

Treatments: Device: Preservation of Hearts for Transplantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02323321

OCS-CAR-012014

Details and patient eligibility

About

To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Registered male or female primary Heart transplant candidate
• Age ≥18 years old

Exclusion criteria

• Prior solid organ or bone marrow transplant
• Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
• Multi-organ transplant

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

OCS Preservation

Experimental group

Description:

OCS Preservation and Assessment

Treatment:

Device: Preservation of Hearts for Transplantation