Status:
COMPLETED
Trip HF Study: Triple Resynchronization in Paced Heeart Failure Patients
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Ventricular Dyssynchrony
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- • 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
- 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.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00187265
Start Date
April 1 2003
End Date
October 1 2005
Last Update
February 4 2019
Active Locations (1)
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1
Department of Cardiology - CHU Pontchaillou
Rennes, France, 35011