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

This study has been completed.
Sponsor:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00180531
First received: September 14, 2005
Last updated: December 12, 2007
Last verified: December 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Monitoring of Arrhythmias and Heart Rate Variability in Patients With Congestive Heart Failure Treated With the Cardiac Resynchronisation Pacemaker Renewal TR2

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
CHG Albi
Albi, France, 81013
CHU Michalon
Grenoble, France, 38043
Hôpital Louis Pradel
Lyon, France, 69394
CH La Croix Rousse
Lyon, France, 69317
Nouvelle Clinique Nantaise
Nantes, France, 44227
CHU Nîmes
Nîmes, France, 30029
CHG Perigueux
Perigueux, France, 24019
Hôpital Pontchaillou
Rennes, France, 35033
Centre Cardiologique du Nord
Saint Denis, France, 93207
Clinique Pasteur
Toulouse, France, 31076
Sponsors and Collaborators
Guidant Corporation
Investigators
Principal Investigator: P. CHEVALIER, MD Hôpital Louis Pradel, Lyon
Principal Investigator: S Boveda, MD Clinique Pasteur
  More Information

No publications provided by Guidant Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elisabeth Mouton, Guidant France
ClinicalTrials.gov Identifier: NCT00180531     History of Changes
Other Study ID Numbers: Mona Lisa v. 1.1 3/12/03
Study First Received: September 14, 2005
Last Updated: December 12, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 20, 2014