Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

447

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started May 2010

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.7 years study duration

Study Start

First participant enrolled

May 1, 2010

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed

Last Updated

February 11, 2014

Status Verified

February 1, 2014

Enrollment Period

3.3 years

First QC Date

February 9, 2014

Last Update Submit

February 9, 2014

Conditions

Heart Failure

Keywords

CRTHEART FAILURE

Outcome Measures

Primary Outcomes (1)

All-cause mortality
36 month follow-up

Secondary Outcomes (1)

Heart failure event or death
36 month follow-up

Study Arms (2)

MADIT-CRT CRT-D

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

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

MADIT-CRT ICD

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

Device: MADIT-CRT ICD ONLY ARM

Interventions

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

Also known as: Boston Scientific market approved cardiac resynchronization therapy defibrillators

MADIT-CRT CRT-D

MADIT-CRT ICD ONLY ARMDEVICE

Also known as: Market approved Boston Scientific implantable cardioverter defibrillators

MADIT-CRT ICD

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

The registry involves only those patients that participated in the MADIT-CRT IDE study within Europe.

You may qualify if:

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

You may not qualify if:

Patients who are unable or unwilling to comply with the protocol requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Sheba Medical Centerlead
Israeli Association for Cardiovascular Trials - IACTcollaborator

Study Sites (1)

Israeli Association for Cardiovascular Trials at Sheba Medical Center

Ramat Gan, Israel

Location

Related Publications (8)

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.
PMID: 19723701BACKGROUND
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.
PMID: 32605387DERIVED
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.
PMID: 30592353DERIVED
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.
PMID: 29759864DERIVED
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.
PMID: 26823498DERIVED
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.
PMID: 26124205DERIVED
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.
PMID: 26038537DERIVED
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.
PMID: 24678999DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Electric Countershock

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Study Design

Study Type: observational
Time Perspective: PROSPECTIVE
Target Duration: 3 Years
Sponsor Type: OTHER GOV
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director of the Israeli Association for Cardiovascular Trials

Study Record Dates

First Submitted

February 9, 2014

First Posted

February 11, 2014

Study Start

May 1, 2010

Primary Completion

September 1, 2013

Study Completion

January 1, 2014

Last Updated

February 11, 2014

Record last verified: 2014-02

Locations

IL(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

MADIT-CRT CRT-D

MADIT-CRT ICD

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (8)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

Locations