CentriMag Failure-to-Wean Post Approval Study

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04464785
Collaborator
(none)
32
Enrollment
13
Locations
49.1
Anticipated Duration (Months)
2.5
Patients Per Site
0.1
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

SiteCityStateCountryPostal Code
1Baptist Healt Medical CenterLittle RockArkansasUnited States72205
2Stanford University Medical CenterPalo AltoCaliforniaUnited States94304
3University of ColoradoAuroraColoradoUnited States80045
4Advent Health OrlandoOrlandoFloridaUnited States32803
5Advocate Christ Medical CenterOak LawnIllinoisUnited States60453
6University of MichiganAnn ArborMichiganUnited States48104
7University of Minnesota Medical Center FairviewMinneapolisMinnesotaUnited States55455
8Barnes Jewish HospitalSaint LouisMissouriUnited States63110
9New York Presbyterian/ Columbia University Medical CenterNew YorkNew YorkUnited States10032
10Carolinas Medical CenterCharlotteNorth CarolinaUnited States28206
11Hospital of the University of PennsylvaniaPhiladelphiaPennsylvaniaUnited States19104
12University of UtahSalt Lake CityUtahUnited States84132
13Medical College of WisconsinMilwaukeeWisconsinUnited States53226

Sponsors and Collaborators

  • Abbott Medical Devices

Investigators

  • Study Director: Poormina Sood, MD, 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:
Dec 3, 2021
Last Verified:
Dec 1, 2021
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 Dec 3, 2021