Role of Left Ventricular Pacing Site

Not Applicable

• Conditions: Heart Failure; Cardiomyopathy, Dilated; Coronary Disease

• Registration Number: NCT00221780
• Lead Sponsor: University Hospital, Bordeaux

Brief 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.

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.

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-28
• Last Update Posted: 2007-06-29
• Study Completion: 2007-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Variation in left ventricular dp/dt max

Secondary Outcome Measures

Name	Time	Method
pressures and volumes of the left ventricle
stroke work
surface ECG repolarisation

Trial Locations

Locations (1)

Hôpital Cardiologique du Haut Lévêque, Rythmology department, Pr CLEMENTY, 3rd Floor; 🇫🇷 Pessac, France