Back to resultsRole of Left Ventricular Pacing Site
Primary Purpose
Heart Failure, Cardiomyopathy, Dilated, Coronary Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
left ventricular pacing
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Cardiomyopathy, dilated, Coronary disease, Cardiac Pacing, Artificial, Hemodynamics, Randomized Controlled Trials, Single-Blind Study
Eligibility Criteria
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
Sites / Locations
- Hôpital Cardiologique du Haut Lévêque, Rythmology department, Pr CLEMENTY, 3rd FloorRecruiting
Outcomes
Primary Outcome Measures
Variation in left ventricular dp/dt max
Secondary Outcome Measures
pressures and volumes of the left ventricle
stroke work
surface ECG repolarisation
Full Information
NCT ID
NCT00221780
First Posted
September 13, 2005
Last Updated
June 28, 2007
Sponsor
University Hospital, Bordeaux
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT00221780
Brief Title
Role of Left Ventricular Pacing Site
Official Title
Importance of Left Ventricular Pacing Site in Biventricular Resynchronization Therapy for Severe Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Unknown status
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Ministry of Health, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cardiomyopathy, Dilated, Coronary Disease
Keywords
Heart failure, Cardiomyopathy, dilated, Coronary disease, Cardiac Pacing, Artificial, Hemodynamics, Randomized Controlled Trials, Single-Blind Study
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
33 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
left ventricular pacing
Primary Outcome Measure Information:
Title
Variation in left ventricular dp/dt max
Secondary Outcome Measure Information:
Title
pressures and volumes of the left ventricle
Title
stroke work
Title
surface ECG repolarisation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Jaïs, Dr
Phone
33 (0) 5 57 65 64 71
Email
pierre.jais@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Jaïs, Dr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Perez, Dr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital Cardiologique du Haut Lévêque, Rythmology department, Pr CLEMENTY, 3rd Floor
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Jaïs, Dr
Phone
33 (0) 5 57 65 64 71
Email
pierre.jais@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Pierre Jaïs, Dr
12. IPD Sharing Statement
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Role of Left Ventricular Pacing Site
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