Trip HF Study: Triple Resynchronization in Paced Heeart Failure Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2005-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Heart Failure Ventricular Dyssynchrony

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Cardiac Resynchronization Therapy

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No