CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,798 enrolled
Drug / intervention
Optimal Medical Therapy plus ICD +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00251251
NCT00251251N/ACompleted

Resynchronization/Defibrillation for Ambulatory Heart Failure Trial

Ottawa Heart Institute Research Corporation·interventional·Posted Nov 9, 2005·Updated Aug 28, 2023

In Brief

A clinical study evaluating Optimal Medical Therapy plus ICD and Optimal Medical Therapy plus CRT/ICD for Heart Failure, Congestive. Completed, enrolled 1,798 participants across 33 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Canada, Denmark, Germany, Netherlands, Turkey (Türkiye)

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 9, 2005
Enrollment StartApr 1, 2003
Primary CompletionSep 1, 2010
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 20.6 years ago

Interventions

Optimal Medical Therapy plus ICDdevice

ICD vs CRT/ICD

Optimal Medical Therapy plus CRT/ICDdevice

ICD vs CRT/ICD