Monitoring of Arrhythmias and HRV in Patients With Heart Failure Treated With the CRT Pacemaker Renewal TR2

Phase 4

Completed

• Conditions: Congestive Heart Failure

• Registration Number: NCT00180531
• Lead Sponsor: Guidant Corporation

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-16
• Study Completion: 2007-06
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-12
• Last Update Posted: 2007-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Occurrence of ventricular arrhythmias
Occurrence of supraventricular arrhythmias

Trial Locations

Locations (10)

Centre Cardiologique du Nord; 🇫🇷 Saint Denis, France

Clinique Pasteur; 🇫🇷 Toulouse, France

Hôpital Louis Pradel; 🇫🇷 Lyon, France

CHU Michalon; 🇫🇷 Grenoble, France

CH La Croix Rousse; 🇫🇷 Lyon, France

CHG Albi; 🇫🇷 Albi, France

Nouvelle Clinique Nantaise; 🇫🇷 Nantes, France

CHU Nîmes; 🇫🇷 Nîmes, France

CHG Perigueux; 🇫🇷 Perigueux, France

Hôpital Pontchaillou; 🇫🇷 Rennes, France