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

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

This study has been completed.

Sponsored by:	Guidant Corporation
Information provided by:	Guidant Corporation
ClinicalTrials.gov Identifier:	NCT00180531

Purpose

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

Condition	Intervention	Phase
Congestive Heart Failure	Device: Renewal TR2	Phase IV

Genetics Home Reference related topics:

Brugada syndrome short QT syndrome

MedlinePlus related topics:

Arrhythmia Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

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

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:

Occurrence of ventricular arrhythmias
Occurrence of supraventricular arrhythmias

Estimated Enrollment:	500
Study Start Date:	February 2004
Study Completion Date:	June 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180531

Locations


France
	Hôpital Louis Pradel
	Lyon, France, 69394
	Clinique Pasteur
	Toulouse, France, 31076
	Hôpital Pontchaillou
	Rennes, France, 35033
	Nouvelle Clinique Nantaise
	Nantes, France, 44227
	CHU Michalon
	Grenoble, France, 38043
	CH La Croix Rousse
	Lyon, France, 69317
	CHG Albi
	Albi, France, 81013
	CHU Nîmes
	Nîmes, France, 30029
	CHG Perigueux
	Perigueux, France, 24019
	Centre Cardiologique du Nord
	Saint Denis, France, 93207

Sponsors and Collaborators

Guidant Corporation

Investigators


Principal Investigator:	P. CHEVALIER, MD	Hôpital Louis Pradel, Lyon

Principal Investigator:	S Boveda, MD	Clinique Pasteur

More Information

Responsible Party:	Guidant France ( Elisabeth Mouton )
Study ID Numbers:	Mona Lisa v. 1.1 3/12/03
First Received:	September 14, 2005
Last Updated:	December 12, 2007
ClinicalTrials.gov Identifier:	NCT00180531
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Heart Failure

Heart Diseases

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 27, 2008