MADIT-CRT: Multicenter Automatic Defibrillator Implantati... | NCT00180271

NCT00180271

ID	Type	Description	Link
MADIT-CRT

Status Module

Sponsor/Collaborators Module

Name	Class
University of Rochester	OTHER

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CRT-D	Experimental	CRT-D: Cardiac resynchronization therapy with defibrillation.	Device: Cardiac resynchronization therapy with defibrillation
ICD	Active Comparator	ICD: Implantable cardioverter defibrillator	Device: Implantable Cardioverter Defibrillator (ICD)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac resynchronization therapy with defibrillation	Device	Boston Scientific Corporation Market Released Cardiac Resynchronization therapy with defibrillation	CRT-D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality From Any Cause or First Heart Failure (HF) Event	MADIT-CRT was an event-driven trial in which patients were monitored for all-cause mortality and HF events. An HF event was defined as either hospitalization for symptoms and/or signs consistent with congestive HF and: administration of intravenous decongestive therapy that does not involve formal in-patient hospital admission, regardless of the setting (i.e. in an emergency room setting, in the physician's office, etc.), or administration of an augmented HF regimen with oral or intravenous medications during an in-hospital stay.	Outcome measured at average follow-up duration of 2.4 years.

Secondary Outcomes

Measure	Description	Time Frame
Recurrent Heart Failure Events	The MADIT-CRT secondary outcome evaluated the effects of CRT-D, relative to ICD, on the recurrence of heart failure events over the full study period An HF event was defined as either hospitalization for symptoms and/or signs consistent with congestive HF and: administration of intravenous decongestive therapy that does not involve formal in-patient hospital admission, regardless of the setting (i.e. in an emergency room setting, in the physician's office, etc.), or administration of an augmented HF regimen with oral or intravenous medications during an in-hospital stay.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ischemic heart disease defined as:
- NYHA Class I or II for the past 3 calendar months prior to, and at the time of, enrollment;
- one or more clinically documented (Q wave or enzyme positive) prior myocardial infarctions, but not within 3 calendar months of enrollment; and/or
- one or more prior coronary artery bypass graft surgeries or percutaneous coronary interventions (balloon and/or stent angioplasty) but not within 3 calendar months of enrollment.

Non-ischemic heart disease including dilated cardiomyopathy characterized by a low ejection fraction and increased ventricular volume, with ventricular compliance that is normal or increased
NYHA Class II for the past 3 calendar months prior to, and at the time of, enrollment

AND all of the following:

Stable optimal pharmacologic therapy.
An ejection fraction < or = 0.30 by angiographic, radionuclide, or echocardiographic methods within one year prior to enrollment and measured during the enrollment echocardiogram obtained within 14 days prior to randomization to confirm eligibility (recommended)
Resting QRS duration > or = 130 ms on print-out of a current electrocardiogram (ECG) obtained within 14 days prior to randomization.
Sinus rhythm by ECG (including right bundle branch block [RBBB] and first degree heart block with PR < 250 ms.)
Men and women 21 years of age or older (no upper-age cut off)

Exclusion Criteria:

Existing indication for CRT
Subjects with an implanted pacemaker
Subjects with an existing ICD or CRT device
Subjects in NYHA Class I with non-ischemic cardiomyopathy
Subjects in NYHA Class III or IV in the past 3 calendar months prior to, or at the time of, enrollment
Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past 3 calendar months prior to enrollment
Enzyme-positive myocardial infarction within the past 3 calendar months prior to enrollment
Subjects with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the foreseeable future
Subjects with second or third degree heart block
Subjects with irreversible brain damage from preexisting cerebral disease
Women who are pregnant or plan to become pregnant during the course of the trial. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
Reversible non-ischemic cardiomyopathy such as acute viral myocarditis or discontinuation of alcohol in alcohol-induced heart disease
Subjects with chronic atrial fibrillation within one month prior to enrollment
Presence of any disease, other than the subject's cardiac disease, associated with a reduced likelihood of survival for the duration of the trial, e.g., cancer, uremia (blood urea nitrogen [BUN] > 70 mg/dl or creatinine > 3.0 mg/dl), liver failure, etc.
Subjects participating in any other clinical trials
Subjects unwilling or unable to cooperate with the protocol
Subjects who live at such a distance from the clinic that travel for follow-up visits would be unusually difficult
Subjects who do not anticipate being residents of the area for the scheduled duration of the trial
Subjects unwilling to sign the consent for participation

Contacts/Locations Module

Name	Affiliation	Role
Arthur J Moss, MD	University of Rochester, NY	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Multiple locations in the US and international		Rochester	New York	14642	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41757453	Derived	Thomas S, McNitt S, Polonsky B, Alexis JD, Bisognano JD, Goldenberg I, Kutyifa V. Effects of Cardiac Resynchronization Therapy on Cardiovascular and Noncardiovascular Hospitalization: A MADIT-CRT Long-Term Follow-Up. J Am Heart Assoc. 2026 Mar 17;15(6):e019880. doi: 10.1161/JAHA.120.019880. Epub 2026 Feb 27.
37671601	Derived

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00065± 11 BG00164± 11 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000275 BG001178 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000757 BG001514 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mortality From Any Cause or First Heart Failure (HF) Event

MADIT-CRT was an event-driven trial in which patients were monitored for all-cause mortality and HF events. An HF event was defined as either hospitalization for symptoms and/or signs consistent with congestive HF and:

administration of intravenous decongestive therapy that does not involve formal in-patient hospital admission, regardless of the setting (i.e. in an emergency room setting, in the physician's office, etc.), or
administration of an augmented HF regimen with oral or intravenous medications during an in-hospital stay.

Analysis was performed on an intention-to-treat basis and counted the time to first event. The category "Patients with Death at Any Time", includes deaths that occurred after the first heart failure event.

Posted

Number

Participants

Outcome measured at average follow-up duration of 2.4 years.

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG0001089 OG001731

Title

Denominators

Categories

Patients who are Event Free

Title	Measurements
	OG000901 OG001543

Patients with Death or Heart Failure Event

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The trial utilized a Wang-Tsiatis (delta=0.1) group-sequential design with 95% power to detect a hazard ratio of 0.75 at a two-sided significance level of 0.05. Primary analysis based on statistical evaluation comparing the life-table event-free survival time graphs for CRT-D and ICD-only arms of the trial. Stratified Cox proportional-hazards regression was used to estimate a hazard ratio and statistical significance was evaluated with the log-rank test. Stratified by center and ischemic status.	Log Rank		< 0.001	The trial involved prespecified event monitoring at up to 20 successive periods by an independent DSMB to permit trial termination if the CRT-D was superior to, inferior to, or not different from ICD according to prespecified stopping rules.	Hazard Ratio (HR)	0.66			2-Sided	95	0.52	0.84

Secondary

Recurrent Heart Failure Events

The MADIT-CRT secondary outcome evaluated the effects of CRT-D, relative to ICD, on the recurrence of heart failure events over the full study period An HF event was defined as either hospitalization for symptoms and/or signs consistent with congestive HF and:

administration of intravenous decongestive therapy that does not involve formal in-patient hospital admission, regardless of the setting (i.e. in an emergency room setting, in the physician's office, etc.), or
administration of an augmented HF regimen with oral or intravenous medications during an in-hospital stay.

Posted

Count of Participants

Participants

Time of event, DSMB review

ID	Title	Description
OG000	CRT-D	CRT-D: Cardiac resynchronization therapy with defibrillation. Cardiac resynchronization therapy with defibrillation: Boston Scientific Corporation Market Released Cardiac Resynchronization therapy with defibrillation
OG001	ICD: Implantable Cardioverter Defibrillator	ICD: Implantable cardioverter defibrillator Implantable Cardioverter Defibrillator (ICD): Boston Scientific Corporation Market Released Implantable Cardioverter Defibrillator

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.			164	1,079	126	1,079
EG001	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.			55	712	0	712

Serious Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Lead Dislodgment, Left Ventricular	Cardiac disorders	Systematic Assessment		EG00051 events46 affected1,079 at risk EG0011 events1 affected712 at risk
Lead Dislodgment, Right Atrial	Cardiac disorders	Systematic Assessment		EG00033 events33 affected1,079 at risk EG00110 events10 affected712 at risk
Pneumothorax	Surgical and medical procedures	Systematic Assessment		EG00015 events15 affected1,079 at risk EG0015 events5 affected712 at risk
Hematoma, Pocket	Surgical and medical procedures	Systematic Assessment		EG00014 events14 affected1,079 at risk EG0015 events5 affected712 at risk
Extracardiac Stimulation, Left Ventricular	Cardiac disorders	Systematic Assessment		EG00011 events11 affected1,079 at risk EG0010 events0 affected712 at risk
Lead Dislodgment, Right Ventricular	Cardiac disorders	Systematic Assessment		EG0008 events8 affected1,079 at risk EG0015 events5 affected712 at risk
Thromboembolic Events	Blood and lymphatic system disorders	Systematic Assessment		EG0008 events8 affected1,079 at risk EG0014 events4 affected712 at risk
Atrioventricular Block	Surgical and medical procedures	Systematic Assessment		EG0006 events6 affected1,079 at risk EG0012 events2 affected712 at risk
Adverse Reaction	Surgical and medical procedures	Systematic Assessment		EG0006 events6 affected1,079 at risk EG0017 events7 affected712 at risk
Elevated Threshold, Right Ventricular	Cardiac disorders	Systematic Assessment		EG0006 events6 affected1,079 at risk EG0013 events3 affected712 at risk
Infection, Post Surgical	Surgical and medical procedures	Systematic Assessment		EG0009 events9 affected1,079 at risk EG0012 events2 affected712 at risk
Inadvertent Ventricular Tachyarrhythmia	Cardiac disorders	Systematic Assessment	Arrhythmia inadvertently induced during implant procedure.	EG0004 events4 affected1,079 at risk EG0012 events2 affected712 at risk
Renal Failure	Surgical and medical procedures	Systematic Assessment	Secondary to use of contrast media	EG0004 events4 affected1,079 at risk EG0010 events0 affected712 at risk
Pericardial Effusion	Surgical and medical procedures	Systematic Assessment		EG0004 events3 affected1,079 at risk EG0011 events1 affected712 at risk
Myocardial Perforation with Tamponade	Surgical and medical procedures	Systematic Assessment		EG0003 events3 affected1,079 at risk EG0011 events1 affected712 at risk
Elevated Defibrillation Thresholds	Cardiac disorders	Systematic Assessment		EG0006 events6 affected1,079 at risk EG0018 events8 affected712 at risk
Hemorrhage, Pocket	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0002 events2 affected1,079 at risk EG0011 events1 affected712 at risk
Inappropriate Tachyarrhythmia Therapy	Cardiac disorders	Systematic Assessment		EG0002 events2 affected1,079 at risk EG0011 events1 affected712 at risk
Early Elective Replacement Indicator	Cardiac disorders	Systematic Assessment		EG0002 events2 affected1,079 at risk EG0011 events1 affected712 at risk
Insulation Breach, Left Ventricular Lead	Cardiac disorders	Systematic Assessment		EG0002 events2 affected1,079 at risk EG0010 events0 affected712 at risk
Inadvertent Supraventricular Tachyarrhythmia	Cardiac disorders	Systematic Assessment		EG0002 events2 affected1,079 at risk EG0010 events0 affected712 at risk
Arterial Perforation	Surgical and medical procedures	Systematic Assessment		EG0001 events1 affected1,079 at risk EG0010 events0 affected712 at risk
Venous Occlusion	Surgical and medical procedures	Systematic Assessment		EG0001 events1 affected1,079 at risk EG0010 events0 affected712 at risk
Seroma, Pocket	Surgical and medical procedures	Systematic Assessment		EG0001 events1 affected1,079 at risk EG0010 events0 affected712 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected1,079 at risk EG0010 events0 affected712 at risk
Worsening Heart Failure	Cardiac disorders	Systematic Assessment		EG0002 events2 affected1,079 at risk EG0011 events1 affected712 at risk
Elevated Threshold, Left Ventricular	Cardiac disorders	Systematic Assessment		EG0001 events1 affected1,079 at risk EG0010 events0 affected712 at risk
Difficulty Measing Impedance/Amplitude	Cardiac disorders	Systematic Assessment		EG0001 events1 affected1,079 at risk EG0010 events0 affected712 at risk
Pulse Generator Migration	Surgical and medical procedures	Systematic Assessment		EG0001 events1 affected1,079 at risk EG0010 events0 affected712 at risk
Set Screws Not Tightened	Surgical and medical procedures	Systematic Assessment		EG0000 events0 affected1,079 at risk EG0013 events3 affected712 at risk
Post Surgical Wound Discomfort	Surgical and medical procedures	Systematic Assessment		EG0000 events0 affected1,079 at risk EG0011 events1 affected712 at risk
Elevated Shock Impedance	Cardiac disorders	Systematic Assessment		EG0001 events1 affected1,079 at risk EG0010 events0 affected712 at risk
Bigeminy	Cardiac disorders	Systematic Assessment		EG0001 events1 affected1,079 at risk EG0010 events0 affected712 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Extracardiac Stimulation, Left Ventricular	Cardiac disorders		Systematic Assessment	Events corrected non-invasively with reprogramming.	EG00077 events70 affected1,079 at risk EG0010 events0 affected712 at risk
Pacemaker Mediated Tachycardia	Cardiac disorders		Systematic Assessment	Events corrected non-invasively with reprogramming.	EG00067 events56 affected1,079 at risk EG0010 events0 affected712 at risk

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.

Certain Agreements

ID	Term
D013610	Tachycardia
D006333	Heart Failure

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D000075224	Cardiac Conduction System Disease
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D058406	Cardiac Resynchronization Therapy
D004554	Electric Countershock
D017147	Defibrillators, Implantable

Ancestor Terms

ID	Term
D002304	Cardiac Pacing, Artificial
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D047548	Defibrillators
D004566	Electrodes
D055615	Electrical Equipment and Supplies
D004864	Equipment and Supplies
D004567	Electrodes, Implanted
D019736	Prostheses and Implants