Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-29 @ 3:55 AM
Study NCT ID:
NCT00119834
Status:
COMPLETED
Last Update Posted:
2018-04-09
First Post:
2005-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)
Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Organization:
Study Overview
Official Title:
Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| N01-HV-18246 | OTHER | NHLBI | View |