Trip HF Study: Triple Resynchronization in Paced Heeart Failure Patients

Abbott

Status

Completed

Conditions

Ventricular Dyssynchrony

Heart Failure

Treatments

Device: Cardiac Resynchronization Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00187265

CR03005HF

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.