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Resynchronization/Defibrillation for Ambulatory Heart Failure Trial

NCT00251251 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1798

Last updated 2023-08-28

No results posted yet for this study

Summary

Congestive heart failure (CHF) is a common health problem that leads to frequent hospitalizations and an increased death rate. In spite of advances in drug therapy, it remains a significant public health problem. Recently, a new therapy has been developed for advanced heart failure patients with a ventricular conduction abnormality. This new therapy, called cardiac resynchronization (CRT), is a device which stimulates the atrium, the right ventricle, and the left ventricle providing synchronization of the contraction of the heart chambers. It is the addition of this therapy to an implantable cardioverter defibrillator (ICD) that will be evaluated in this study. This study will compare whether the implantation of this new therapy device, in combination with an implantable cardioverter defibrillator, will reduce total mortality and hospitalizations for CHF.

Conditions

  • Heart Failure, Congestive

Interventions

DEVICE

Optimal Medical Therapy plus ICD

ICD vs CRT/ICD

DEVICE

Optimal Medical Therapy plus CRT/ICD

ICD vs CRT/ICD

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Medtronic

    collaborator INDUSTRY

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Principal Investigators

  • Anthony Tang, MD · Ottawa Heart Institute Research Corporation

  • George Wells, PhD · Ottawa Heart Institute Research Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2010-09-30
Completion
2011-05-31

Countries

  • Australia
  • Belgium
  • Canada
  • Denmark
  • Germany
  • Netherlands
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00251251 on ClinicalTrials.gov