Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)

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ClinicalTrials.gov Identifier: NCT00119834

Recruitment Status : Completed

First Posted : July 14, 2005

Last Update Posted : April 9, 2018

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Sponsor:

Information provided by (Responsible Party):

National Heart, Lung, and Blood Institute (NHLBI)

Study Description

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.

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

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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 transplantation, a bridge to recovery, and 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.

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 Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) 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:

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

Intermacs has included pediatric patients since the inception of the registry in 2006 with an increased effort in September 2012 to include pediatric subjects. 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.

Intermacs now serves as the national quality improvement system to assess the characteristics, treatments and outcomes of patients receiving legally utilized mechanical circulatory support devices. The protocol has undergone several changes since its inception in 2006. The Current protocol (Protocol 5.0) reflects the latest changes and the necessity for a waiver of informed consent and authorization for participants.

In January 2013 the Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support (Medamacs) was established to capture data on patients with advanced heart failure who were not receiving mechanical circulatory support devices. The aims of Medamacs are to:

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.
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.
Evaluate patient perceptions about their cardiac condition, ventricular assist device technology, preferences for their care, and thresholds for considering device implant.

Enrollment in Medamacs has closed.

The clinicaltrials.gov identification number for Medamacs is NCT01932294.

Study Design

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Study Type :	Observational
Actual Enrollment :	23472 participants
Observational Model:	Case-Only
Time Perspective:	Other
Official Title:	Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)
Actual Study Start Date :	June 2005
Actual Primary Completion Date :	December 31, 2017
Actual Study Completion Date :	December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Groups and Cohorts

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.

Outcome Measures

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	1 Day and older (Child, Adult, Older Adult)
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

Locations

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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Principal Investigator:	James K. Kirklin, MD	University of Alabama at Birmingham

More Information

Additional Information:

Click here for the Interagency Registry of Mechanically Assisted Circulatory Support (INTERMACS) web site This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00119834
Other Study ID Numbers:	1296 N01-HV-18246 ( Other Identifier: NHLBI )
First Posted:	July 14, 2005 Key Record Dates
Last Update Posted:	April 9, 2018
Last Verified:	April 2018
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.

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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:

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Heart Failure Cardiovascular Diseases Heart Diseases

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