This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Guidant Corporation Identifier:
First received: September 14, 2005
Last updated: December 12, 2007
Last verified: December 2007
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: None (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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00180531

CHG Albi
Albi, France, 81013
CHU Michalon
Grenoble, France, 38043
CH La Croix Rousse
Lyon, France, 69317
Hôpital Louis Pradel
Lyon, France, 69394
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
Principal Investigator: P. CHEVALIER, MD Hôpital Louis Pradel, Lyon
Principal Investigator: S Boveda, MD Clinique Pasteur
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Elisabeth Mouton, Guidant France 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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on August 17, 2017