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

September 13, 2005
June 28, 2007
November 2003
Not Provided
Variation in left ventricular dp/dt max
Same as current
Complete list of historical versions of study NCT00221780 on ClinicalTrials.gov Archive Site
  • pressures and volumes of the left ventricle
  • stroke work
  • surface ECG repolarisation
  • - pressures and volumes of the left ventricle
  • - stroke work
  • - surface ECG repolarisation
Not Provided
Not Provided
 
Role of Left Ventricular Pacing Site
Importance of Left Ventricular Pacing Site in Biventricular Resynchronization Therapy for Severe Heart Failure

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Heart Failure
  • Cardiomyopathy, Dilated
  • Coronary Disease
Device: left ventricular pacing
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
33
December 2007
Not Provided

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
Both
18 Years and older
No
Contact: Pierre Jaïs, Dr 33 (0) 5 57 65 64 71 pierre.jais@chu-bordeaux.fr
France
 
NCT00221780
9426-01, 2001-030
No
Not Provided
University Hospital, Bordeaux
Ministry of Health, France
Principal Investigator: Pierre Jaïs, Dr University Hospital, Bordeaux
Study Chair: Paul Perez, Dr University Hospital, Bordeaux
University Hospital, Bordeaux
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP