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Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation

Primary Purpose

Heart Failure, Congestive, Ventricular Fibrillation, Tachycardia, Ventricular

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Cardiac Resynchronization Therapy with Defibrillation

About this trial

This is an interventional treatment trial for Heart Failure, Congestive

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

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

Sites / Locations

Multiple locations

Outcomes

Primary Outcome Measures

Composite of all-cause mortality, heart failure hospitalization, and ventricular tachyarrhythmia

Secondary Outcome Measures

Peak VO2

NYHA Class

Six minute walk distance

Quality of life

Echocardiographic measures

Full Information

NCT ID

NCT00387803

First Posted

October 11, 2006

Last Updated

January 23, 2007

Sponsor

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00387803

Brief Title

Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation

Official Title

VENTAK CHF/CONTAK CD Biventricular Pacing Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Completed

Study Start Date

February 1998 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Boston Scientific Corporation

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Congestive, Ventricular Fibrillation, Tachycardia, Ventricular

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

581 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Cardiac Resynchronization Therapy with Defibrillation

Primary Outcome Measure Information:

Title

Composite of all-cause mortality, heart failure hospitalization, and ventricular tachyarrhythmia

Secondary Outcome Measure Information:

Title

Peak VO2

Title

NYHA Class

Title

Six minute walk distance

Title

Quality of life

Title

Echocardiographic measures

10. Eligibility

Sex

All

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Higgins, MD

Organizational Affiliation

Scripps Memorial Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Leslie A Saxon, MD

Organizational Affiliation

University of California San Francisco Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

John Boehmer, MD

Organizational Affiliation

Milton S. Hershey Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Teresa De Marco, MD

Organizational Affiliation

University of California San Francisco Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Multiple locations

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55112

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

14563591

Citation

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.

Results Reference

result

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Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation

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