Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)

NCT00119834 | Completed DMC

• 2 other identifiers: 1296N01-HV-18246
• Study Type: observational
• Target: 23,472
• Locations: 1 country
• Sites: 1

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 life in patients with advanced heart failure.

Conditions

Cardiovascular Diseases; Heart Diseases; Heart Failure, Congestive

Keywords

Heart Failure; Intermacs; Pedimacs; Mechanical Circulatory Support; Ventricular Assist Device

Outcome Measures

Primary Outcomes (1)

• Collect and analyze clinical and laboratory data from patients who are receiving mechanical circulatory support devices (MCSD) for end-stage heart failure.

  Collected as part of the registry

Interventions

Mechanical Circulatory Support Device (MCSD) DEVICE

INTERMACS is an observational registry of adult and pediatric patients with end stage heart failure that receive a legally utilized Mechanical Circulatory Support Device.

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with end-stage heart failure that receive a legally utilized mechanical circulatory support device.

You may qualify if:

• 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

You may not qualify if:

• Currently incarcerated

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Brisco MA, Kimmel SE, Coca SG, Putt ME, Jessup M, Tang WW, Parikh CR, Testani JM. Prevalence and prognostic importance of changes in renal function after mechanical circulatory support. Circ Heart Fail. 2014 Jan;7(1):68-75. doi: 10.1161/CIRCHEARTFAILURE.113.000507. Epub 2013 Nov 8.

  PMID: 24214901 DERIVED

Related Links

• Click here for the Interagency Registry of Mechanically Assisted Circulatory Support (INTERMACS) web site

Biospecimen

Retention: SAMPLES WITH DNA

DNA sample collection was an optional portion of the project during the first contract period (2005-2010). Tissue and Blood specimens were collected at the time of implant, explant or exchange of the mechanical circulatory assist device. Intermacs no longer collects blood or tissue specimens.

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Heart Failure

Study Officials

• James K. Kirklin, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2005
• First Posted: July 14, 2005
• Study Start: June 1, 2005
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: April 9, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)