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Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry (MADIT-CRT PAR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01294449
First Posted: February 11, 2011
Last Update Posted: December 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
  Purpose

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 Intervention
Heart Failure Device: MADIT-CRT ICD Device: MADIT-CRT CRT-D

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • All-Cause Mortality [ Time Frame: 5 years ]
    Outcome measured for total population. Not broken down by indication received.


Enrollment: 394
Study Start Date: March 2011
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MADIT-CRT ICD 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
MADIT-CRT CRT-D 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

Detailed Description:
The registry is designed to determine the long-term mortality benefit as a result of Cardiac Resynchronization Therapy with Defibrillation (CRT-D) vs. Implantable Cardioverter Defibrillator (ICD) therapy in the MADIT-CRT study patient population. The registry will collect data on patients that previously participated at MADIT-CRT sites within the US through five years of participation from their orginal enrollment in the MADIT-CRT IDE study (MADIT-CRT IDE: NCT00180271).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The registry involves only those patients that participated in the MADIT-CRT IDE study within the United States.
Criteria

Inclusion Criteria:

  • Active patients who were enrolled in the MADIT-CRT IDE (NCT00180271)within the United States

Exclusion Criteria:

  • Patients who are unable or unwilling to comply with the protocol requirements
  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): NCT01294449


Locations
United States, New York
University of Rochester /Strong Memorial
Rochester, New York, United States, 14642
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Arthur J Moss, MD University of Rochester Heart Research Follow-up Program
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Biton Y, Kutyifa V, Cygankiewicz I, Goldenberg I, Klein H, McNitt S, Polonsky B, Ruwald AC, Ruwald MH, Moss AJ, Zareba W. Relation of QRS Duration to Clinical Benefit of Cardiac Resynchronization Therapy in Mild Heart Failure Patients Without Left Bundle Branch Block: The Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy Substudy. Circ Heart Fail. 2016 Feb;9(2):e002667. doi: 10.1161/CIRCHEARTFAILURE.115.002667.
Biton Y, Zareba W, Goldenberg I, Klein H, McNitt S, Polonsky B, Moss AJ, Kutyifa V; MADIT‐CRT Executive Committee. Sex Differences in Long-Term Outcomes With Cardiac Resynchronization Therapy in Mild Heart Failure Patients With Left Bundle Branch Block. J Am Heart Assoc. 2015 Jun 29;4(7). pii: e002013. doi: 10.1161/JAHA.115.002013.
Daimee UA, Moss AJ, Biton Y, Solomon SD, Klein HU, McNitt S, Polonsky B, Zareba W, Goldenberg I, Kutyifa V. Long-Term Outcomes With Cardiac Resynchronization Therapy in Patients With Mild Heart Failure With Moderate Renal Dysfunction. Circ Heart Fail. 2015 Jul;8(4):725-32. doi: 10.1161/CIRCHEARTFAILURE.115.002082. Epub 2015 Jun 2.
Goldenberg I, Kutyifa V, Klein HU, Cannom DS, Brown MW, Dan A, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Kautzner J, Klempfner R, Kuniss M, Merkely B, Pfeffer MA, Quesada A, Viskin S, McNitt S, Polonsky B, Ghanem A, Solomon SD, Wilber D, Zareba W, Moss AJ. Survival with cardiac-resynchronization therapy in mild heart failure. N Engl J Med. 2014 May 1;370(18):1694-701. doi: 10.1056/NEJMoa1401426. Epub 2014 Mar 30.
Skali H, Dwyer EM, Goldstein R, Haigney M, Krone R, Kukin M, Lichstein E, McNitt S, Moss AJ, Pfeffer MA, Solomon SD. Prognosis and response to therapy of first inpatient and outpatient heart failure event in a heart failure clinical trial: MADIT-CRT. Eur J Heart Fail. 2014 May;16(5):560-5. doi: 10.1002/ejhf.71. Epub 2014 Feb 27.
Campbell P, Takeuchi M, Bourgoun M, Shah A, Foster E, Brown MW, Goldenberg I, Huang DT, McNitt S, Hall WJ, Moss A, Pfeffer MA, Solomon SD; Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy (MADIT-CRT) Investigators. Right ventricular function, pulmonary pressure estimation, and clinical outcomes in cardiac resynchronization therapy. Circ Heart Fail. 2013 May;6(3):435-42. doi: 10.1161/CIRCHEARTFAILURE.112.000127. Epub 2013 Mar 22.

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01294449     History of Changes
Other Study ID Numbers: MADIT-CRT PAR
First Submitted: February 7, 2011
First Posted: February 11, 2011
Results First Submitted: August 25, 2014
Results First Posted: December 4, 2014
Last Update Posted: December 4, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases


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