Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Cardiovascular Diseases; Heart Failure, Congestive
• Intervention / Treatment: Device: Mechanical Circulatory Support Device (MCSD)

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:

1. 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
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

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:

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.

Enrollment in Medamacs has closed.

The clinicaltrials.gov identification number for Medamacs is NCT01932294.

• Study Type: Observational
• Enrollment (Actual): 23472

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: James K. Kirklin, MD, University of Alabama at Birmingham

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2005
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: July 6, 2005
• First Submitted That Met QC Criteria: July 6, 2005
• First Posted (Estimate): July 14, 2005

Study Record Updates

• Last Update Posted (Actual): April 9, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Heart Failure; Ventricular Assist Device; Mechanical Circulatory Support; Intermacs; Pedimacs
• Additional Relevant MeSH Terms: Heart Failure; Heart Diseases; Cardiovascular Diseases
• Other Study ID Numbers: 1296; N01-HV-18246 (Other Identifier: NHLBI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) is not available. De-identified datasets may be available upon approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No