Heart Failure, Ventricular Dyssynchrony
Conditions
Brief summary
The purpose of this study is to evaluate the feasibility of permanent biventricular pacing using three ventricular leads, and its efficacy in terms of inter and intra-ventricular resynchronization, in patients with congestive heart failure and a non-functional atrium (chronic AF).
Interventions
DEVICECardiac Resynchronization Therapy
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• NYHA class III-IV congestive heart failure, in spite of optimal medical treatment for their congestive heart failure for 1 month. The medical treatment must include a 40 mg/day minimum dose of furosemide (or equivalent); * Permanent atrial fibrillation (AF); * Left ventricular ejection fraction (LVEF) ≤ 35%; * Indication for a pacemaker implantation for a permanent and symptomatic bradycardia, or already implanted pacemaker under the condition that leads positioning corresponds to the criteria described in the protocol; * Aortic pre-ejection delay at least equal to 140 ms.
Exclusion criteria
* Indication for a cardiac defibrillator; * Having presented a myocardial infarct within the previous 3 months; * Having undergone cardiac surgery or coronary revascularization procedure within the previous 3 months, or being scheduled for such procedures; * Presenting chronic pulmonary insufficiency; * Patients whose congestive heart failure requires the use of an intravenous inotropic support; * Presenting a dysthyreosis; * Having a life expectancy of less than one year, for other reasons than the congestive heart failure; * Unable to be followed-up in the scope of the study for geographical reasons; * Having refused to give their consent; * Minors (age \< 18 years) and pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Z-ratio | — |
Countries
France
Outcome results
None listed