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Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry

NCT ID: NCT01294449

Last Updated: 2014-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

394 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-11-30

Brief Summary

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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)

Detailed Description

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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).

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MADIT-CRT ICD

MADIT-CRT ICD

Intervention Type DEVICE

Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.

MADIT-CRT CRT-D

MADIT-CRT CRT-D

Intervention Type DEVICE

Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.

Interventions

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MADIT-CRT ICD

Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.

Intervention Type DEVICE

MADIT-CRT CRT-D

Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.

Intervention Type DEVICE

Other Intervention Names

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Market approved Boston Scientific implantable cardioverter defibrillators Boston Scientific market approved cardiac resynchronization therapy defibrillators

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arthur J Moss, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester Heart Research Follow-up Program

Locations

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University of Rochester /Strong Memorial

Rochester, New York, United States

Site Status

Countries

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United States

References

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Vidula H, Lee E, McNitt S, Polonsky B, Aktas M, Rosero S, Younis A, Solomon SD, Zareba W, Kutyifa V, Goldenberg I. Cardiac Resynchronization Therapy and Risk of Recurrent Hospitalizations in Patients Without Left Bundle Branch Block: The Long-Term Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy. Circ Heart Fail. 2020 Jul;13(7):e006925. doi: 10.1161/CIRCHEARTFAILURE.120.006925. Epub 2020 Jul 1.

Reference Type DERIVED
PMID: 32605387 (View on PubMed)

Kutyifa V, Vermilye K, Solomon SD, McNitt S, Moss AJ, Daimee UA. Long-term outcomes of cardiac resynchronization therapy by left ventricular ejection fraction. Eur J Heart Fail. 2019 Mar;21(3):360-369. doi: 10.1002/ejhf.1357. Epub 2018 Dec 28.

Reference Type DERIVED
PMID: 30592353 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26823498 (View on PubMed)

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):e002013. doi: 10.1161/JAHA.115.002013.

Reference Type DERIVED
PMID: 26124205 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26038537 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24678999 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24578164 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23524528 (View on PubMed)

Other Identifiers

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MADIT-CRT PAR

Identifier Type: -

Identifier Source: org_study_id