Trip HF Study: Triple Resynchronization in Paced Heeart Failure Patients

Not Applicable

Completed

• Conditions: Heart Failure; Ventricular Dyssynchrony

• Registration Number: NCT00187265
• Lead Sponsor: Abbott Medical Devices

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Study Completion: 2005-10
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Z-ratio

Trial Locations

Locations (1)

Department of Cardiology - CHU Pontchaillou; 🇫🇷 Rennes, France