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NCT05047068 · ClinicalTrials.gov registry record

OCS Heart Perfusion Post-Approval Registry

A clinical trial of Transplant, sponsored by TransMedics.

Active
Registry status
350
Enrollment target
20
Study locations

NCT05047068: Active study of Transplant, sponsored by TransMedics.

NCT05047068 is a study of Transplant that is active but no longer recruiting, run by TransMedics. The registered enrollment target is 350 participants, above the 177-participant average among 5 other Transplant trials with a reported enrollment target (98% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05047068, a study of Transplant, is active but no longer recruiting, sponsored by TransMedics.

ACTIVE NOT RECRUITING
Registry status
350 participants
Enrollment target
20
Study locations

Study Summary

The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts.

Primary Outcome

Patient survival at one-year post-heart transplant.

Conditions Studied

Interventions

  • DEVICE OCS Heart System

Study Locations (20)

California

  • Cedars Sinai - Los Angeles
  • Stanford University - Palo Alto
  • University of California San Francisco - San Francisco

Massachusetts

  • Tufts Medical Center - Boston
  • Massachusetts General Hospital - Boston
  • Brigham and Women's Hospital - Boston

Minnesota

  • Minneapolis Heart Institute - Minneapolis
  • University of Minnesota - Minneapolis
  • Mayo Clinic Rochester - Rochester

New York

  • Columbia University Irving Medical Center/ New York Presbyterian Hospital - New York
  • Montefiore - The Bronx
  • Westchester Medical Center - Valhalla

Florida

  • Mayo Clinic Florida - Jacksonville
  • Tampa General Hospital - Tampa

Connecticut

  • Yale New Haven Hospital - New Haven

Georgia

  • Emory University Hospital - Atlanta

Illinois

  • Northwestern Medicine - Chicago

Trial Details

FieldValue
Enrollment Target 350 participants
Start Date 2021-09-13
Est. Completion 2029-12
TransMedics

23 total trials

What the registry record for NCT05047068 still lists

NCT05047068 is an observational study that tracks outcomes without assigning an intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, above the 177-participant average among 5 other Transplant trials with a reported enrollment target (98% higher).

The record links to 1 condition, with Transplant appearing as the primary indexed condition, and to 1 intervention - of which OCS Heart System is the first listed.

NCT05047068 names 20 study sites across 11 states, led by California, Massachusetts, Minnesota.

Frequently Asked Questions

What is clinical trial NCT05047068 about?

NCT05047068 is a clinical study titled "OCS Heart Perfusion Post-Approval Registry". The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts.

What is the current status of trial NCT05047068?

This trial is currently active not recruiting. The enrollment target is 350 participants. The study started on 2021-09-13. Estimated completion is 2029-12.

What conditions does trial NCT05047068 study?

This clinical trial studies the following conditions: Transplant.

What interventions are being tested in trial NCT05047068?

The interventions under investigation include: OCS Heart System (DEVICE).

Who is sponsoring clinical trial NCT05047068?

This trial is sponsored by TransMedics, which has 23 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05047068 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Transplant

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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Source: ClinicalTrials.gov NCT05047068, the US trial registry maintained by the National Library of Medicine. NCT05047068 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.