Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry (MADIT-CRT PAR)
|ClinicalTrials.gov Identifier: NCT01294449|
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : December 4, 2014
Last Update Posted : December 4, 2014
MADIT-CRT PAR is an FDA mandated follow-up registry for patients that participated in the MADIT-CRT IDE study examining long-term mortality.
(MADIT-CRT IDE: NCT00180271)
|Condition or disease||Intervention/treatment|
|Heart Failure||Device: MADIT-CRT ICD Device: MADIT-CRT CRT-D|
|Study Type :||Observational|
|Actual Enrollment :||394 participants|
|Official Title:||Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||November 2013|
Device: MADIT-CRT ICD
Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
Other Name: Market approved Boston Scientific implantable cardioverter defibrillators
Device: MADIT-CRT CRT-D
Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
Other Name: Boston Scientific market approved cardiac resynchronization therapy defibrillators
- All-Cause Mortality [ Time Frame: 5 years ]Outcome measured for total population. Not broken down by indication received.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01294449
|United States, New York|
|University of Rochester /Strong Memorial|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Arthur J Moss, MD||University of Rochester Heart Research Follow-up Program|