Clinical trial NCT00180531: Monitoring of Arrhythmias and HRV in Patients With Heart Failure Treated With the CRT Pacemaker Renewal TR2
Official title: Monitoring of Arrhythmias and Heart Rate Variability in Patients With Congestive Heart Failure Treated With the Cardiac Resynchronisation Pacemaker Renewal TR2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Congestive Heart Failure
Lead sponsor: Guidant Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


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.

Primary outcomes:
measure: Occurrence of ventricular arrhythmias
measure: Occurrence of supraventricular arrhythmias
Secondary outcomes:
Other outcomes:
Locations:
city: Albi
country: France
facility: CHG Albi
city: Grenoble
country: France
facility: CHU Michalon
city: Lyon
country: France
facility: CH La Croix Rousse
city: Lyon
country: France
facility: Hôpital Louis Pradel
city: Nantes
country: France
facility: Nouvelle Clinique Nantaise
city: Nîmes
country: France
facility: CHU Nîmes
city: Perigueux
country: France
facility: CHG Perigueux
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Saint Denis
country: France
facility: Centre Cardiologique du Nord
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
affiliation: Hôpital Louis Pradel, Lyon
name: P. CHEVALIER, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Pasteur
name: S Boveda, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boveda S, Marijon E, Jacob S, Defaye P, Winter JB, Bulava A, Gras D, Albenque JP, Combes N, Pavin D, Delarche N, Teubl A, Lambiez M, Chevalier P; Mona Lisa Study Group. Incidence and prognostic significance of sustained ventricular tachycardias in heart failure patients implanted with biventricular pacemakers without a back-up defibrillator: results from the prospective, multicentre, Mona Lisa cohort study. Eur Heart J. 2009 May;30(10):1237-44. doi: 10.1093/eurheartj/ehp071. Epub 2009 Mar 4.