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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180531
First Posted: September 16, 2005
Last Update Posted: December 13, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Guidant Corporation
  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: 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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180531


Locations
France
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
Investigators
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 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
First Submitted: September 14, 2005
First Posted: September 16, 2005
Last Update Posted: December 13, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases