NCT00187265CompletedNot Applicable
Triple Resynchronization in Paced Heart Failure Patients
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Locations
- 1
- Primary Endpoint
- Z-ratio
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Z-ratio
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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