Monitoring of Arrhythmias and Heart Rate Variability in Patients With Congestive Heart Failure Treated With the Cardiac Resynchronisation Pacemaker Renewal TR2

Guidant Corporation10 sites in 1 country500 target enrollmentFebruary 2004

ConditionsCongestive Heart Failure

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Congestive Heart Failure
Sponsor: Guidant Corporation
Enrollment: 500
Locations: 10
Primary Endpoint: Occurrence of ventricular arrhythmias
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the prevalence of sustained ventricular and supraventricular rhythm disorders in patients implanted with a CONTAK RENEWAL TR2 ventricular resynchronization therapy (CRT) device

Registry

clinicaltrials.gov

Start Date

February 2004

End Date

June 2007

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Guidant Corporation

Eligibility Criteria

Inclusion Criteria

•Moderate or severe chronic heart failure, defined by the presence of NYHA class III or IV symptoms, Intra/interventricular synchronization disorder evaluated by echocardiography and/or Doppler Tissue Imaging (DTI, Yu's method22), Ejection fraction (EF) ≤ 40 %, If previous history of myocardial infarction, MI must be \> 60 days from the date of inclusion, Estimated life expectancy \> 6 months in the case of concomitant disease, Age ≥ 18 years, Optimal drug treatment of chronic heart failure (according to SFC\* recommendations).

Exclusion Criteria

•Conventional indication for treatment by implantable defibrillator upon inclusion, Cardiac transplant envisaged within 6 months, Unexplained syncope, MI \< 60 days before inclusion, Non compliance to drug treatment for chronic heart failure, Any coronary pathology which may be treated by revascularisation.