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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
Est. primary completion date
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


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
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