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Role of Left Ventricular Pacing Site

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by University Hospital, Bordeaux.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00221780
First received: September 13, 2005
Last updated: June 28, 2007
Last verified: June 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00221780     History of Changes
Other Study ID Numbers: 9426-01, 2001-030
Study First Received: September 13, 2005
Last Updated: June 28, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on November 25, 2014