MADIT-CRT: Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy

This study has been completed.

Study NCT00180271 Information provided by Boston Scientific Corporation

First Received on September 9, 2005. Last Updated on January 24, 2012 History of Changes

Results First Received: February 23, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Tachycardia Congestive Heart Failure
Interventions:	Device: Cardiac resynchronization therapy with defibrillation Device: Implantable Cardioverter Defibrillator (ICD)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study enrolled 1820 patients from 110 hospital centers (88 in the United States, 2 in Canada, and 20 in Europe) between December 22, 2004 and April 23, 2008. Follow-up continued thereafter until trial termination.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Data from all patients enrolled were analyzed on an intention-to-treat basis.

Reporting Groups

	Description
Cardiac Resynchronization Therapy + Defibrillator	Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
Implantable Cardioverter Defibrillator Alone	Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.

Participant Flow: Overall Study

	Cardiac Resynchronization Therapy + Defibrillator	Implantable Cardioverter Defibrillator Alone
STARTED	1089	731
COMPLETED	1089	731
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Cardiac Resynchronization Therapy + Defibrillator	Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
Implantable Cardioverter Defibrillator Alone	Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.

Baseline Measures

	Cardiac Resynchronization Therapy + Defibrillator	Implantable Cardioverter Defibrillator Alone	Total
Number of Participants [units: participants]	1089	731	1820
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	543	380	923
>=65 years	546	351	897
Age [units: years] Mean ± Standard Deviation	65 ± 11	64 ± 11	65 ± 11
Gender [units: participants]
Female	275	178	453
Male	814	553	1367
Region of Enrollment [units: participants]
United States	757	514	1271
Canada	14	8	22
Czech Republic	17	11	28
Denmark	22	13	35
France	13	9	22
Germany	98	61	159
Hungary	16	10	26
Israel	45	30	75
Italy	15	12	27
Netherlands	34	24	58
Poland	14	10	24
Spain	36	24	60
Switzerland	4	2	6
United Kingdom	4	3	7

Outcome Measures

1. Primary:

Mortality From Any Cause or First Heart Failure (HF) Event [ Time Frame: Outcome measured at average follow-up duration of 2.4 years. ]

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2. Secondary:

Recurrent Heart Failure Events [ Time Frame: Time of event, DSMB review ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The FDA Circulatory Devices advisory panel recommended approval for the patient subpopulation with left bundle branch block (LBBB) only. Consequently, FDA has restricted indications for use to LBBB.

Results Point of Contact:

Name/Title: Lisa Melchior
Organization: Boston Scientific
phone: 800 227 3422
e-mail: lisa.melchior@bsci.com

No publications provided by Boston Scientific Corporation

Publications automatically indexed to this study:

Goldenberg I, Moss AJ, Hall WJ, Foster E, Goldberger JJ, Santucci P, Shinn T, Solomon S, Steinberg JS, Wilber D, Barsheshet A, McNitt S, Zareba W, Klein H; MADIT-CRT Executive Committee. Predictors of response to cardiac resynchronization therapy in the multicenter automatic defibrillator implantation trial with cardiac resynchronization therapy (MADIT-CRT). Circulation. 2011 Oct 4;124(14):1527-36. Epub 2011 Sep 6.

Goldenberg I, Hall WJ, Beck CA, Moss AJ, Barsheshet A, McNitt S, Polonsky S, Brown MW, Zareba W. Reduction of the risk of recurring heart failure events with cardiac resynchronization therapy: MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy). J Am Coll Cardiol. 2011 Aug 9;58(7):729-37.

Barsheshet A, Wang PJ, Moss AJ, Solomon SD, Al-Ahmad A, McNitt S, Foster E, Huang DT, Klein HU, Zareba W, Eldar M, Goldenberg I. Reverse remodeling and the risk of ventricular tachyarrhythmias in the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy). J Am Coll Cardiol. 2011 Jun 14;57(24):2416-23.

Knappe D, Pouleur AC, Shah AM, Cheng S, Uno H, Hall WJ, Bourgoun M, Foster E, Zareba W, Goldenberg I, McNitt S, Pfeffer MA, Moss AJ, Solomon SD; Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy Investigators. Dyssynchrony, contractile function, and response to cardiac resynchronization therapy. Circ Heart Fail. 2011 Jul 1;4(4):433-40. Epub 2011 May 22.

Zareba W, Klein H, Cygankiewicz I, Hall WJ, McNitt S, Brown M, Cannom D, Daubert JP, Eldar M, Gold MR, Goldberger JJ, Goldenberg I, Lichstein E, Pitschner H, Rashtian M, Solomon S, Viskin S, Wang P, Moss AJ; MADIT-CRT Investigators. Effectiveness of Cardiac Resynchronization Therapy by QRS Morphology in the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy (MADIT-CRT). Circulation. 2011 Mar 15;123(10):1061-72. Epub 2011 Feb 28.

Martin DT, McNitt S, Nesto RW, Rutter MK, Moss AJ. Cardiac resynchronization therapy reduces the risk of cardiac events in patients with diabetes enrolled in the multicenter automatic defibrillator implantation trial with cardiac resynchronization therapy (MADIT-CRT). Circ Heart Fail. 2011 May 1;4(3):332-8. Epub 2011 Feb 24.

Arshad A, Moss AJ, Foster E, Padeletti L, Barsheshet A, Goldenberg I, Greenberg H, Hall WJ, McNitt S, Zareba W, Solomon S, Steinberg JS; MADIT-CRT Executive Committee. Cardiac resynchronization therapy is more effective in women than in men the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy) trial. J Am Coll Cardiol. 2011 Feb 15;57(7):813-20.

Solomon SD, Foster E, Bourgoun M, Shah A, Viloria E, Brown MW, Hall WJ, Pfeffer MA, Moss AJ; MADIT-CRT Investigators. Effect of cardiac resynchronization therapy on reverse remodeling and relation to outcome: multicenter automatic defibrillator implantation trial: cardiac resynchronization therapy. Circulation. 2010 Sep 7;122(10):985-92. Epub 2010 Aug 23.

Barsheshet A, Goldenberg I, Narins CR, Moss AJ, McNitt S, Wang PJ, Huang DT, Hall WJ, Zareba W, Eldar M, Guetta V. Time dependence of life-threatening ventricular tachyarrhythmias after coronary revascularization in MADIT-CRT. Heart Rhythm. 2010 Oct;7(10):1421-7. Epub 2010 Jul 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. Epub 2009 Sep 1.

Responsible Party:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00180271 History of Changes
Other Study ID Numbers:	Clinicals0003, MADIT-CRT
Study First Received:	September 9, 2005
Results First Received:	February 23, 2011
Last Updated:	January 24, 2012
Health Authority:	United States: Food and Drug Administration