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Role of Left Ventricular Pacing Site

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2007 by University Hospital, Bordeaux.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00221780
First Posted: September 22, 2005
Last Update Posted: June 29, 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.
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Bordeaux
  Purpose
Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site. We study in a random order 11 different left ventricular pacing sites and compare their hemodynamics using pressure-volume catheters. The consequences on the surface ECG are also assessed.

Condition Intervention
Heart Failure Cardiomyopathy, Dilated Coronary Disease Device: left ventricular pacing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Importance of Left Ventricular Pacing Site in Biventricular Resynchronization Therapy for Severe Heart Failure

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Variation in left ventricular dp/dt max

Secondary Outcome Measures:
  • pressures and volumes of the left ventricle
  • stroke work
  • surface ECG repolarisation

Estimated Enrollment: 33
Study Start Date: November 2003
Estimated Study Completion Date: December 2007
Detailed Description:

Background. Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site.

Design. Single-blind, monocentric, randomized cross-over study comparing 11 left ventricular pacing sites in a random order.

Intervention. Left ventricular DDD pacing on 11 ventricular sites, prior to the implantation. At each pacing site, a control hemodynamics will be obtained in AAI pacing at the same pacing rate. At each pacing site, 2 AV delays, a short and a long one, will be assessed.

Eligibility criteria. Patients referred for cardiac resynchronization therapy for heart failure

Outcomes. Hemodynamic measures using pressure-volume catheters.

  Eligibility

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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:

  • Heart failure referred for cardiac resynchronization therapy
  • NYHA Class III or IV
  • Informed consent form signed

Exclusion Criteria:

  • Hypertension not controlled by treatment
  • Coronary ischemia not controlled by treatment
  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): NCT00221780


Contacts
Contact: Pierre Jaïs, Dr 33 (0) 5 57 65 64 71 pierre.jais@chu-bordeaux.fr

Locations
France
Hôpital Cardiologique du Haut Lévêque, Rythmology department, Pr CLEMENTY, 3rd Floor Recruiting
Pessac, France, 33604
Contact: Pierre Jaïs, Dr    33 (0) 5 57 65 64 71    pierre.jais@chu-bordeaux.fr   
Principal Investigator: Pierre Jaïs, Dr         
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry of Health, France
Investigators
Principal Investigator: Pierre Jaïs, Dr University Hospital, Bordeaux
Study Chair: Paul Perez, Dr University Hospital, Bordeaux
  More Information

ClinicalTrials.gov Identifier: NCT00221780     History of Changes
Other Study ID Numbers: 9426-01
2001-030
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: June 29, 2007
Last Verified: June 2007

Keywords provided by University Hospital, Bordeaux:
Heart failure
Cardiomyopathy, dilated
Coronary disease
Cardiac Pacing, Artificial
Hemodynamics
Randomized Controlled Trials
Single-Blind Study

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Coronary Disease
Coronary Artery Disease
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cardiomegaly