CentriMag Failure-to-Wean Post Approval Study

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04464785
Collaborator
(none)
32
13
49.1
2.5
0.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: CentriMag Circulatory Support System

Study Design

Study Type:
Observational
Anticipated Enrollment :
32 participants
Official Title:
CentriMag Failure-to-Wean Post-Approval Study
Actual Study Start Date :
Dec 30, 2020
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Jan 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Treatment

Subjects who receive the CentriMag Circulatory Support System

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.

Outcome Measures

Primary Outcome Measures

  1. Survival to 30 days Post CentriMag support or to hospital discharge [30 days]

    The proportion of subjects who survive to 30 days post CentriMag support or to hospital discharge (whichever is longer).

  2. Survival to induction of anesthesia for surgery for transplant or a long-term system [Approximately 30 days]

    The proportion of subjects who do not recover and are bridged to a transplant or long-term system

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Subject >18 years of age

  • Subject or legal representative has signed Informed Consent Form (ICF)

  • Subject has CentriMag Circulatory Support System implanted due to Failure To Wean from Cardiopulmonary Bypass

Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baptist Healt Medical Center Little Rock Arkansas United States 72205
2 Stanford University Medical Center Palo Alto California United States 94304
3 University of Colorado Aurora Colorado United States 80045
4 Advent Health Orlando Orlando Florida United States 32803
5 Advocate Christ Medical Center Oak Lawn Illinois United States 60453
6 University of Michigan Ann Arbor Michigan United States 48104
7 University of Minnesota Medical Center Fairview Minneapolis Minnesota United States 55455
8 Barnes Jewish Hospital Saint Louis Missouri United States 63110
9 New York Presbyterian/ Columbia University Medical Center New York New York United States 10032
10 Carolinas Medical Center Charlotte North Carolina United States 28206
11 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
12 University of Utah Salt Lake City Utah United States 84132
13 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

Sponsors and Collaborators

  • Abbott Medical Devices

Investigators

  • Study Director: Sara Ahmed, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT04464785
Other Study ID Numbers:
  • ABT-CIP-10336
First Posted:
Jul 9, 2020
Last Update Posted:
Jun 24, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 24, 2022