Cardiac Resynchronization Therapy with Defibrillation in Ventricular Fibrillation and Tachycardia, Ventricular and Heart Failure, Congestive - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Device: Cardiac Resynchronization Therapy with Defibrillation

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.

Study Type

Interventional

Enrollment

581

Phase

Phase 2
Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Minnesota
  - Saint Paul, Minnesota, United States, 55112
    - Multiple locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Quality of life
Peak VO2
NYHA Class
Six minute walk distance
Echocardiographic measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

Principal Investigator: John Boehmer, MD, Milton S. Hershey Medical Center
Principal Investigator: Steven Higgins, MD, Scripps Memorial Hospital
Principal Investigator: Leslie A Saxon, MD, University Of California San Francisco Medical Center
Principal Investigator: Teresa De Marco, MD, University Of California San Francisco Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1998

Study Completion

August 1, 2001

Study Registration Dates

First Submitted

October 11, 2006

First Submitted That Met QC Criteria