- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00187213
B-Left HF: Biventricular Versus Left Univentricular Pacing With Implantable Cardiac Defibrillator (ICD) Back-Up in Heart Failure Patients
Biventricular Versus Left Univentricular Pacing With ICD Back-up in Heart Failure Patients
The purpose of this study is to demonstrate that biventricular pacing (BiV) and left univentricular (left ventricular [LV] only) pacing are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a cardiac resynchronization therapy defibrillator (CRT-D) device.
The hypothesis to be tested by this clinical investigation is that patients indicated for an ICD with cardiac resynchronization therapy respond as well to LV only pacing as to BiV pacing.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rennes, France, 35011
- Department of Cardiology - CHU Pontchaillou
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have an approved indication for implantation of an ICD for treatment of a life-threatening ventricular tachyarrhythmia(s)
- Have advanced heart failure with a New York Heart Association (NYHA) classification of III or IV, despite receiving a minimum of 30 days of stable optimal pharmacological therapy
- Have a ventricular conduction delay manifested as a QRS width >= 130 ms
- Have a left ventricular end diastolic diameter (LVEDD) >= 55 mm
- Have a left ventricular ejection fraction (LVEF) <= 35%
Exclusion Criteria:
- Have a CRT device already implanted
- Have a standard indication for bradycardia pacing
- Have a history of chronic atrial fibrillation [AF] (continuous AF lasting > 1 month) within 1 year prior to enrollment or have undergone cardioversion for AF in the past month)
- Have the ability to walk > 450 meters during the 6-minute walk test
- Have uncorrected primary valvular disease
- Have had a recent myocardial infarction, unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty [PTCA] or coronary artery bypass graft [CABG]) within 1 month of enrollment
- Have had cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment
- Have a life expectancy of less than one year
- Are unable to comply with the follow-up schedule and tests
- Are minors (age below 18 years)
- Are pregnant or are planning for pregnancy in the next 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary objective is to demonstrate that left univentricular pacing is equivalent to biventricular pacing in improving the functional capacity and inducing reverse remodeling.
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Secondary Outcome Measures
Outcome Measure |
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The secondary objective of this clinical investigation is to evaluate the proportion of improved patients in each group, using the Heart Failure Clinical Composite Response.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christophe Leclercq, MD, PhD, CHU Pontchaillou Rennes France
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR03019HF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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