Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS)

This study is currently recruiting participants.
Verified August 2013 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: August 13, 2013
Last verified: August 2013
  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.
Detailed Description:

Background:

Over the last two decades, MCSDs have been developed to augment or supplant failing myocardial performance. This therapy has been used successfully as a bridge to heart transplantation, occasionally as a bridge to recovery, and most recently as permanent implantation or "destination therapy" for intractable heart failure. Although heart transplantation offers life-saving therapy for selected patients, its use is limited by a supply of donor organs that currently meets less than one-tenth the need. As a consequence, the number of MCSD implantations has increased in recent years, and this trend is expected to continue especially in light of the October 1, 2003 decision of the Centers for Medicare and Medicaid Services (CMS) to provide reimbursement for MCSD implantation surgery.

Despite favorable survival and quality of life outcomes, MCSDs do have severe and sometimes life-threatening complications, including infection, thrombosis, and device failure. The development of new procedures and devices to reduce these complications will be expedited by the work of the registry involving the systematic, independent analysis of MCSD implantation procedures and outcomes. The National Heart, Lung, and Blood Institute (NHLBI) will collaborate with the CMS and the Food and Drug Administration in monitoring the work of the registry to permit the development of standard reporting of patient characteristics, indications, implantation procedures, and adverse events.

INTERMACS Design Narrative:

The goals of the registry include the following:

  1. Develop standard methods to collect data and specimens used to characterize heart failure patients receiving MCSDs, and develop methods of collecting demographic data of device use patient outcomes
  2. Collect, process, and store patients' clinical data
  3. Analyze collected data
  4. Provide these resources to researchers outside the registry
  5. Publish and disseminate results

PediMACS Update:January 2013

INTERMACS has included pediatric patients since the inception of the registry in 2006. However, in September 2012 an increased effort to include pediatric subjects was implemented. This focus is called pediMACS. PediMACS utilizes the INTERMACS protocol. Due to collection of pediatric-only data elements, a separate Users' Guide has been developed for pediMACS.

MedaMACS Update: January 2013

The Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support (MedaMACS) has been established to capture data on patients with advanced heart failure who were not receiving mechanical circulatory support devices. The aims of MedaMACS are to:

  1. Identify prospectively a population of ambulatory patients on optimal medical therapy for whom chronic heart failure limits both function and survival to a range where elective implantation of left ventricular assist devices should offer meaningful benefit.
  2. Design an integrated endpoint of survival and objective functional assessment that provides more discrimination between chronic ambulatory heart failure and current device outcomes than survival alone.
  3. Evaluate patient perceptions about their cardiac condition, ventricular assist device technology, preferences for their care, and thresholds for considering device implant.
  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)
  • 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
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: August 13, 2013
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 April 17, 2014