Role of Left Ventricular Pacing Site

Heart Failure Clinical Trial

Official title:

Importance of Left Ventricular Pacing Site in Biventricular Resynchronization Therapy for Severe Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00221780
• Other study ID #: 9426-01
• Secondary ID: 2001-030
• Status: Recruiting
• Phase: N/A
• First received: September 13, 2005
• Last updated: June 28, 2007
• Start date: November 2003
• Est. completion date: December 2007

Study information

• Verified date: June 2007
• Source: University Hospital, Bordeaux
• Contact: Pierre Jaïs, Dr
• Phone: 33 (0) 5 57 65 64 71
• Email: pierre.jais[@]chu-bordeaux.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Coronary Artery Disease
• Coronary Disease
• Heart Failure

Intervention

Device:
• left ventricular pacing

Locations

Country	Name	City	State
France	Hôpital Cardiologique du Haut Lévêque, Rythmology department, Pr CLEMENTY, 3rd Floor	Pessac

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation in left ventricular dp/dt max
Secondary	pressures and volumes of the left ventricle
Secondary	stroke work
Secondary	surface ECG repolarisation