Biventricular Epicardial Pacing Post Cardiac Surgery in Patients With Left Ventricular Ejection Fractions Less Than 45%
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Biventricular pacing post cardiac surgery
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Biventricular pacing, resynchronisation therapy, cardiac surgery, ejection fraction of less 45%
Eligibility Criteria
Inclusion Criteria:
- Planned CABG and/or valve surgery
- Left ventricular dysfunction (EF≤ 45%)
- Age > 18 years
- able to give written information consent
Exclusion Criteria:
- Existing permanent pace maker
- Atrial fibrillation
- Enrolment in other research protocols
- Inability to give written informed consent
- Heart transplant
- Pre operative cardiovascular instability
Sites / Locations
- CHU
Outcomes
Primary Outcome Measures
Determine whether biventricular pacing optimized by trans thoracic echocardiography of left ventricular will improve the heart function
Secondary Outcome Measures
Full Information
NCT ID
NCT00604110
First Posted
January 17, 2008
Last Updated
January 29, 2008
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT00604110
Brief Title
Biventricular Epicardial Pacing Post Cardiac Surgery in Patients With Left Ventricular Ejection Fractions Less Than 45%
Official Title
Interest in Biventricular Epicardial Pacing Post Cardiac Surgery in Patients With Left Ventricular Ejection Fractions Less Than 45%
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
September 2008 (Anticipated)
Study Completion Date
October 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
5. Study Description
Brief Summary
Patients with reduced left ventricular function are at an increased perioperative risk and often need prolonged postoperative treatment on intensive care units. A significant portion of these patients require postoperative pacing. Right ventricular pacing has been shown to be hemodynamically deleterious The aim of this study is to determine which biventricular pacing after cardiac surgery, in patients with reduced left ventricular function (EF≤ 45%), is hemodynamically favourable.
Detailed Description
Some patients with left ventricular systolic dysfunction (LVSD) have an inefficient pumping function. These patients have been shown to benefit from a device therapy known as biventricular pacing. Biventricular pacing causes a more coordinated contraction of the heart chambers resulting in improvement in the pumping ability of the heart and blood pressure. Cardiac Resynchronization Therapy (CRT) has established itself as a proven therapy for congestive heart failure in adults, patients showing improvement in exercise tolerance, quality of life, and survival.
In cardiac surgery, a significant number of these patients with left ventricular systolic dysfunction require postoperative pacing. Right ventricular pacing has been shown to be hemodynamically deleterious Whether biventricular pacing in patients with LVSD improves patient outcomes after heart surgery has not been investigated.
The aim of this crossover trial is to compare conventional ventricular pacing and DDD-biventricular in post operative patients with a pre operative ejection fraction less than 45%, in a prospective randomized setting.
We would like to determine whether biventricular pacing optimized by trans thoracic echocardiography of left ventricular, immediately after heart surgery in patients with LVSD will improve the heart function.
Immediately after surgery, the patients will receive atrio ventricular conventional right ventricular pacing, or biventricular pacing depending upon the treatment arm that they were randomized to.
The primary end point is a 15 % improvement in index cardiac measured by thermal dilution and/or echocardiography in intensive care unit.
Furthermore, Plasma N-terminal pro-brain natriuretic peptide (NT-proBNP), cardiac troponin T (cTnT), will be measured in patients undergoing elective cardiac surgery 12 h, 24 h, 48 h and 72 hours after.
This study is important because of a high probability of clinical benefit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Biventricular pacing, resynchronisation therapy, cardiac surgery, ejection fraction of less 45%
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Biventricular pacing post cardiac surgery
Intervention Description
Determine which biventricular pacing after cardiac surgery, in patients with reduced left ventricular function (EF<45%), is hemodynamically favourable.
Primary Outcome Measure Information:
Title
Determine whether biventricular pacing optimized by trans thoracic echocardiography of left ventricular will improve the heart function
Time Frame
immediately after heart surgery in patients with LVSD
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Planned CABG and/or valve surgery
Left ventricular dysfunction (EF≤ 45%)
Age > 18 years
able to give written information consent
Exclusion Criteria:
Existing permanent pace maker
Atrial fibrillation
Enrolment in other research protocols
Inability to give written informed consent
Heart transplant
Pre operative cardiovascular instability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles De Riberolles, Pr
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stéphane Combes, Dr
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Clermont-Ferrand
State/Province
Auvergne
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
18489775
Citation
Forestier C, Guelon D, Cluytens V, Gillart T, Sirot J, De Champs C. Oral probiotic and prevention of Pseudomonas aeruginosa infections: a randomized, double-blind, placebo-controlled pilot study in intensive care unit patients. Crit Care. 2008;12(3):R69. doi: 10.1186/cc6907. Epub 2008 May 20.
Results Reference
derived
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Biventricular Epicardial Pacing Post Cardiac Surgery in Patients With Left Ventricular Ejection Fractions Less Than 45%
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