Trial · NCT00180271

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

NCT00180271, Not applicable, Completed, Boston Scientific Corporation; results first posted 2011-06-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. MADIT-CRT: Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy. Trials, record NCT00180271. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00180271

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: MADIT-CRT: Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy
NCT number: NCT00180271
Status: Completed
Phases: Not applicable
Enrollment: 1,820 participants, actual
Lead sponsor: Boston Scientific Corporation
Conditions: Tachycardia, Congestive Heart Failure
Interventions: Cardiac resynchronization therapy with defibrillation, Implantable Cardioverter Defibrillator (ICD)
First posted: 2005-09-16
Last updated: 2018-12-19
Results first posted: 2011-06-02
Limitations and caveats: 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.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mortality From Any Cause or First Heart Failure (HF) Event	Outcome measured at average follow-up duration of 2.4 years.	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: 1. 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 2. administration of an augmented HF regimen with oral or intravenous medications during an in-hospital stay.
Secondary	Recurrent Heart Failure Events	Time of event, DSMB review	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: 1. 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 2. administration of an augmented HF regimen with oral or intravenous medications during an in-hospital stay.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mortality From Any Cause or First Heart Failure (HF) Event	Outcome measured at average follow-up duration of 2.4 years.	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.	Participants	NUMBER
SECONDARY	Recurrent Heart Failure Events	Time of event, DSMB review		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Mortality From Any Cause or First Heart Failure (HF) Event	Cardiac Resynchronization Therapy + Defibrillator	Patients who are Event Free	901	Participants
Mortality From Any Cause or First Heart Failure (HF) Event	Implantable Cardioverter Defibrillator Alone	Patients who are Event Free	543	Participants
Mortality From Any Cause or First Heart Failure (HF) Event	Cardiac Resynchronization Therapy + Defibrillator	Patients with Death or Heart Failure Event	188	Participants
Mortality From Any Cause or First Heart Failure (HF) Event	Implantable Cardioverter Defibrillator Alone	Patients with Death or Heart Failure Event	188	Participants
Mortality From Any Cause or First Heart Failure (HF) Event	Cardiac Resynchronization Therapy + Defibrillator	Patients with Heart Failure Event Alone	152	Participants
Mortality From Any Cause or First Heart Failure (HF) Event	Implantable Cardioverter Defibrillator Alone	Patients with Heart Failure Event Alone	170	Participants
Mortality From Any Cause or First Heart Failure (HF) Event	Cardiac Resynchronization Therapy + Defibrillator	Patients with Death at Any Time	74	Participants
Mortality From Any Cause or First Heart Failure (HF) Event	Implantable Cardioverter Defibrillator Alone	Patients with Death at Any Time	53	Participants
Recurrent Heart Failure Events	CRT-D	Participants with 0 events	928	Participants
Recurrent Heart Failure Events	ICD: Implantable Cardioverter Defibrillator	Participants with 0 events	545	Participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cardiac Resynchronization Therapy + Defibrillator	1,089
Overall Study	STARTED	Implantable Cardioverter Defibrillator Alone	731
Overall Study	COMPLETED	Cardiac Resynchronization Therapy + Defibrillator	1,089
Overall Study	COMPLETED	Implantable Cardioverter Defibrillator Alone	731
Overall Study	NOT COMPLETED	Cardiac Resynchronization Therapy + Defibrillator	0
Overall Study	NOT COMPLETED	Implantable Cardioverter Defibrillator Alone	0

Source ClinicalTrials.gov

Adverse events70

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Extracardiac Stimulation, Left Ventricular	Cardiac disorders	Cardiac Resynchronization Therapy + Defibrillator	70	1,079	77
other	Extracardiac Stimulation, Left Ventricular	Cardiac disorders	Implantable Cardioverter Defibrillator Alone	0	712	0
other	Pacemaker Mediated Tachycardia	Cardiac disorders	Cardiac Resynchronization Therapy + Defibrillator	56	1,079	67
other	Pacemaker Mediated Tachycardia	Cardiac disorders	Implantable Cardioverter Defibrillator Alone	0	712	0
serious	Lead Dislodgment, Left Ventricular	Cardiac disorders	Cardiac Resynchronization Therapy + Defibrillator	46	1,079	51
serious	Lead Dislodgment, Left Ventricular	Cardiac disorders	Implantable Cardioverter Defibrillator Alone	1	712	1
serious	Lead Dislodgment, Right Atrial	Cardiac disorders	Cardiac Resynchronization Therapy + Defibrillator	33	1,079	33
serious	Lead Dislodgment, Right Atrial	Cardiac disorders	Implantable Cardioverter Defibrillator Alone	10	712	10
serious	Pneumothorax	Surgical and medical procedures	Cardiac Resynchronization Therapy + Defibrillator	15	1,079	15
serious	Pneumothorax	Surgical and medical procedures	Implantable Cardioverter Defibrillator Alone	5	712	5

1 to 10 of 70Source ClinicalTrials.gov

See all 70 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cardiac Resynchronization Therapy + Defibrillator
Total, all-cause mortality	Implantable Cardioverter Defibrillator Alone
Total, other adverse events	Cardiac Resynchronization Therapy + Defibrillator	126	1,079
Total, other adverse events	Implantable Cardioverter Defibrillator Alone	0	712
Total, serious adverse events	Cardiac Resynchronization Therapy + Defibrillator	164	1,079
Total, serious adverse events	Implantable Cardioverter Defibrillator Alone	55	712

Source ClinicalTrials.gov

Papers59

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19723701	DERIVED	PubMed
20620231	DERIVED	PubMed
20733097	DERIVED	PubMed
21310317	DERIVED	PubMed
21350054	DERIVED	PubMed
21357819	DERIVED	PubMed
21382893	DERIVED	PubMed
21602574	DERIVED	PubMed
21658562	DERIVED	PubMed
21816309	DERIVED	PubMed

1 to 10 of 59

See all 59 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Cardiac Resynchronization Therapy + Defibrillator vs Implantable Cardioverter Defibrillator Alone: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00180271

GET https://conductscience.org/api/trials/v1/NCT00180271/events?page=2

API reference For AI assistants