OCS Heart EXPAND + CAP Continued Follow-Up

NCT ID: NCT05096299

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-16

Study Completion Date

2026-08-31

Brief Summary

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Post-approval observational study of subjects that were enrolled and transplanted in the OCS Heart EXPAND and OCS Heart EXPAND CAP studies.

Detailed Description

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Conditions

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Heart Transplant

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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OCS Heart

Transplanted with OCS preserved heart.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients transplanted in the OCS Heart EXPAND and EXPAND CAP trials
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TransMedics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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OCS-HEART-02-PAS

Identifier Type: -

Identifier Source: org_study_id

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