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CentriMag Failure-to-Wean Post Approval Study

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Locations
United States
Study Type
Observational
Intervention
CentriMag Circulatory Support System
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baptist Healt Medical CenterRecruiting
  • Stanford University Medical CenterRecruiting
  • University of Colorado
  • Advent Health OrlandoRecruiting
  • Advocate Christ Medical CenterRecruiting
  • University of MichiganRecruiting
  • University of Minnesota Medical Center FairviewRecruiting
  • Barnes Jewish HospitalRecruiting
  • New York Presbyterian/ Columbia University Medical CenterRecruiting
  • Carolinas Medical CenterRecruiting
  • Hospital of the University of PennsylvaniaRecruiting
  • University of UtahRecruiting
  • Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm Type

Arm Label

Treatment

Arm Description

Subjects who receive the CentriMag Circulatory Support System

Outcomes

Primary Outcome Measures

Survival to 30 days Post CentriMag support or to hospital discharge
The proportion of subjects who survive to 30 days post CentriMag support or to hospital discharge (whichever is longer).
Survival to induction of anesthesia for surgery for transplant or a long-term system
The proportion of subjects who do not recover and are bridged to a transplant or long-term system

Secondary Outcome Measures

Full Information

First Posted
July 7, 2020
Last Updated
October 5, 2023
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT04464785
Brief Title
CentriMag Failure-to-Wean Post Approval Study
Official Title
CentriMag Failure-to-Wean Post-Approval Study
Study Type
Observational

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 30, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Description
Subjects who receive the CentriMag Circulatory Support System
Intervention Type
Device
Intervention Name(s)
CentriMag Circulatory Support System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival to 30 days Post CentriMag support or to hospital discharge
Description
The proportion of subjects who survive to 30 days post CentriMag support or to hospital discharge (whichever is longer).
Time Frame
30 days
Title
Survival to induction of anesthesia for surgery for transplant or a long-term system
Description
The proportion of subjects who do not recover and are bridged to a transplant or long-term system
Time Frame
Approximately 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: • Concomitant use of Extracorporeal Membrane Oxygenation (ECMO) during CentriMag Circulatory Support System implantation due to FTW from CPB
Study Population Description
Male and female subjects who fail-to-wean from cardiopulmonary bypass.
Sampling Method
Non-Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hua-Wen Ding, MD, PhD
Phone
+32488151239
Email
huawen.ding@abbott.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Ahmed
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Baptist Healt Medical Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol Mudy, MD
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Hiesinger, MD
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Withdrawn
Facility Name
Advent Health Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Silvestry, MD
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antone Tatooles, MD
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis Pagani, MD
Facility Name
University of Minnesota Medical Center Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Shaffer, MD
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Masood, MD
Facility Name
New York Presbyterian/ Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koji Takeda, MD
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Skipper, MD
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Bermudez, MD
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Selzman, MD
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucian Durham, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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CentriMag Failure-to-Wean Post Approval Study

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