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| Sponsors and Collaborators: |
University Hospital, Bordeaux Ministry of Health, France |
|---|---|
| Information provided by: | University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT00221780 |
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: | Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Importance of Left Ventricular Pacing Site in Biventricular Resynchronization Therapy for Severe Heart Failure |
| Estimated Enrollment: | 33 |
| Study Start Date: | November 2003 |
| Estimated Study Completion Date: | December 2007 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Pierre Jaïs, Dr | 33 (0) 5 57 65 64 71 | pierre.jais@chu-bordeaux.fr |
| 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 | |
| Principal Investigator: | Pierre Jaïs, Dr | University Hospital, Bordeaux |
| Study Chair: | Paul Perez, Dr | University Hospital, Bordeaux |
More Information
| Study ID Numbers: | 9426-01, 2001-030 |
| Study First Received: | September 13, 2005 |
| Last Updated: | June 28, 2007 |
| ClinicalTrials.gov Identifier: | NCT00221780 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Heart failure Cardiomyopathy, dilated Coronary disease Cardiac Pacing, Artificial |
Hemodynamics Randomized Controlled Trials Single-Blind Study |
|
Arterial Occlusive Diseases Coronary Disease Heart Failure Heart Diseases Myocardial Ischemia Cardiomyopathy, Dilated |
Vascular Diseases Arteriosclerosis Ischemia Cardiomegaly Cardiomyopathies Coronary Artery Disease |
|
Arterial Occlusive Diseases Coronary Disease Heart Failure Heart Diseases Myocardial Ischemia Cardiomyopathy, Dilated |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Cardiomegaly Cardiomyopathies Coronary Artery Disease |
