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International EXPAND Heart Pivotal Trial (EXPANDHeart)

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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)

75 participants in 1 patient group

OCS Preservation
Experimental group
Description:
OCS Preservation and Assessment
Treatment:
Device: Preservation of Hearts for Transplantation

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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