MADIT-CRT LONG-TERM INTERNATIONAL FOLLOW-UP REGISTRY - EUROPE

NCT ID: NCT02060110

Last Updated: 2014-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

447 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-01-31

Brief Summary

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The registry is designed to determine the long-term mortality and morbidity 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 Europe through five years of participation from their orginal enrollment in the MADIT-CRT IDE study.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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MADIT-CRT CRT-D

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

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

Intervention Type DEVICE

MADIT-CRT ICD

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

MADIT-CRT ICD ONLY ARM

Intervention Type DEVICE

Interventions

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

Intervention Type DEVICE

MADIT-CRT ICD ONLY ARM

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

Active patients who were enrolled in the MADIT-CRT IDE within Europe

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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Israeli Association for Cardiovascular Trials - IACT

UNKNOWN

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof. Ilan Goldenberg, MD

Director of the Israeli Association for Cardiovascular Trials

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Israeli Association for Cardiovascular Trials at Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

References

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Moss AJ, Hall WJ, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Wilber D, Zareba W; MADIT-CRT Trial Investigators. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009 Oct 1;361(14):1329-38. doi: 10.1056/NEJMoa0906431. Epub 2009 Sep 1.

Reference Type BACKGROUND
PMID: 19723701 (View on PubMed)

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)

Sabbag A, Goldenberg I, Moss AJ, McNitt S, Glikson M, Biton Y, Jackson L, Polonsky B, Zareba W, Kutyifa V. Predictors and Risk of Ventricular Tachyarrhythmias or Death in Black and White Cardiac Patients: A MADIT-CRT Trial Substudy. JACC Clin Electrophysiol. 2016 Aug;2(4):448-455. doi: 10.1016/j.jacep.2016.03.003. Epub 2016 May 18.

Reference Type DERIVED
PMID: 29759864 (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)

Other Identifiers

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SHEBA-12-9492-IG-CTIL

Identifier Type: -

Identifier Source: org_study_id

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