Trial record 10 of 162 for:    heart failure OR congestive heart failure OR cor pulmonale | Open Studies | NIH, U.S. Fed

Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Heart, Lung, and Blood Institute (NHLBI)
Sponsor:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00119834
First received: July 6, 2005
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

The purpose of this registry is to collect and analyze clinical and laboratory data from patients who are receiving mechanical circulatory support devices (MCSD) for end-stage heart failure.


Condition Intervention Phase
Cardiovascular Diseases
Heart Diseases
Heart Failure, Congestive
Device: Mechanical Circulatory Support Device (MCSD)
Phase 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Collect and analyze clinical and laboratory data from patients who are receiving mechanical circulatory support devices (MCSD) for end-stage heart failure. [ Time Frame: Collected as part of the registry ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 12000
Study Start Date: June 2005
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Mechanical Circulatory Support Device (MCSD)
    INTERMACS is an observational registry of adult and pediatric patients with end stage heart failure that receive a FDA approved Mechanical Circulatory Support Device.
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with end-stage heart failure that receive a FDA approved mechanical circulatory support device.

Criteria

Inclusion Criteria:

  • FDA approved 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 Criteria:

  • Currently incarcerated
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119834

Contacts
Contact: Mary Lynne Clark 205-934-2555 mlclark@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
Investigators
Principal Investigator: James K. Kirklin, MD University of Alabama at Birmingham
  More Information

Additional Information:
No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00119834     History of Changes
Other Study ID Numbers: 1296, N01-HV-18246
Study First Received: July 6, 2005
Last Updated: April 17, 2014
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Heart Failure
Intermacs
Pedimacs
Mechanical Circulatory Support

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Heart Failure

ClinicalTrials.gov processed this record on August 28, 2014