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Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)

This study is currently recruiting participants.
Verified June 2017 by National Heart, Lung, and Blood Institute (NHLBI)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00119834
First Posted: July 14, 2005
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
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.

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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Other
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 ]

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: 22000
Study Start Date: June 2005
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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 legally utilized Mechanical Circulatory Support Device.
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with end-stage heart failure that receive a legally utilized mechanical circulatory support device.
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • Currently incarcerated
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119834


Contacts
Contact: Jeanne Anne Love, MS 205-975-3905 jfowler@uabmc.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: James K. Kirklin, MD University of Alabama at Birmingham
  More Information

Additional Information:
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 ( Other Identifier: NHLBI )
First Submitted: July 6, 2005
First Posted: July 14, 2005
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) is not available. De-identified datasets may be available upon approval.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases