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

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180531
• Other study ID #: Mona Lisa v. 1.1 3/12/03
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: December 12, 2007
• Start date: February 2004
• Est. completion date: June 2007

Study information

• Verified date: December 2007
• Source: Guidant Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Renewal TR2

Locations

Country	Name	City	State
France	CHG Albi	Albi
France	CHU Michalon	Grenoble
France	CH La Croix Rousse	Lyon
France	Hôpital Louis Pradel	Lyon
France	Nouvelle Clinique Nantaise	Nantes
France	CHU Nîmes	Nîmes
France	CHG Perigueux	Perigueux
France	Hôpital Pontchaillou	Rennes
France	Centre Cardiologique du Nord	Saint Denis
France	Clinique Pasteur	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Guidant Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of ventricular arrhythmias
Primary	Occurrence of supraventricular arrhythmias