Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation

NCT ID: NCT00387803

Last Updated: 2007-01-25

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

Clinical Phase

PHASE2/PHASE3

Total Enrollment

581 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-02-28

Study Completion Date

2001-08-31

Brief Summary

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The purpose of this study was to determine if cardiac resynchronization therapy when combined with defibrillation is safe and effective in the treatment of symptomatic heart failure.

Detailed Description

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Patients enrolled received a device with cardiac resynchronization therapy (CRT) and defibrillation. Patients were randomized to CRT on or off for up to six months and evaluated for mortality, hospitalization, and functional outcomes including exercise capacity, quality of life, symptomatic status, and echocardiographic analysis.

Conditions

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Heart Failure, Congestive Ventricular Fibrillation Tachycardia, Ventricular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Cardiac Resynchronization Therapy with Defibrillation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Symptomatic heart failure
* Left ventricular ejection fraction \<= 35%
* QRS width \>= 120 ms
* Indicated for an implantable cardioverter defibrillator

Exclusion Criteria

* Indicated for a pacemaker
* Atrial tachyarrhythmias
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Principal Investigators

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Steven Higgins, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Memorial Hospital

Leslie A Saxon, MD

Role: PRINCIPAL_INVESTIGATOR

University of California San Francisco Medical Center

John Boehmer, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Teresa De Marco, MD

Role: PRINCIPAL_INVESTIGATOR

University of California San Francisco Medical Center

Locations

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Multiple locations

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

References

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Higgins SL, Hummel JD, Niazi IK, Giudici MC, Worley SJ, Saxon LA, Boehmer JP, Higginbotham MB, De Marco T, Foster E, Yong PG. Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias. J Am Coll Cardiol. 2003 Oct 15;42(8):1454-9. doi: 10.1016/s0735-1097(03)01042-8.

Reference Type RESULT
PMID: 14563591 (View on PubMed)

Other Identifiers

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Clinicals0010

Identifier Type: -

Identifier Source: org_study_id

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