Status:
COMPLETED
Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Diseases
Heart Diseases
Eligibility:
All Genders
1+ years
Brief Summary
The Intermacs registry is a national quality improvement system designed to advance the understanding and application of mechanical circulatory support in order to improve the duration and quality of ...
Detailed Description
Background: Over the last several decades, MCSDs have been developed to augment or supplant failing myocardial performance. This therapy has been used successfully as a bridge to heart transplantatio...
Eligibility Criteria
Inclusion
- Legally utilized MCSD implanted on or after March 1, 2006; every consented patient who receives an eligible MCSD at a participating center will be enrolled, regardless of reason (i.e., bridge-to-recovery, bridge-to-alternative bridge, bridge-to-clinical improvement for transplant eligibility, bridge-to-transplant, destination therapy). Beginning June 1, 2014, and with lnstitutional Review Board approval, participating sites may enroll patients under a waiver of informed consent and authorization.
- Eligible devices include all of the following: 1) approved devices for any indications; 2) Intermacs-linked trial of investigational device or approved device for investigational indications, for which data will be entered via the Intermacs framework; 3) external trial of investigational device or approved device for investigational indications, for which data will be collected by an external group; 4) compassionate use of investigational devices or approved devices outside of approved indications or clinical trials
Exclusion
- Currently incarcerated
Key Trial Info
Start Date :
June 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
23472 Patients enrolled
Trial Details
Trial ID
NCT00119834
Start Date
June 1 2005
End Date
December 31 2017
Last Update
April 9 2018
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294