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CentriMag Failure-to-Wean Post Approval Study

NCT04464785 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2024-12-11

No results posted yet for this study

Summary

The primary objective of this Post Approval Study is to report the proportion of patients surviving to 30 days post CentriMag support or to hospital discharge, whichever is longer. For subjects who do not recover and are bridged to a heart transplant or a long-term assist device, the primary endpoint is survival to induction of anesthesia for the surgery.

Conditions

Interventions

DEVICE

CentriMag Circulatory Support System

The CentriMag Circulatory Suppose System is indicated for providing support for up to 30 days for one or both ventricles of the heart to treat post-cardiotomy patients who fail-to-wean from cardiopulmonary bypass, providing a bridge to decision when it is unclear whether the patient's heart will recover or whether the patient will need alternative, longer-term therapy.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Brian Crowe · Abbott

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-30
Primary Completion
2024-10-25
Completion
2024-10-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04464785 on ClinicalTrials.gov