Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function Study

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

TERMINATED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-05-31

Brief Summary

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The purpose of this study is to compare chronic (1-year) effects on left ventricular ejection fraction resulting from transvenous pacing of the right ventricular apex (RVA) versus the left ventricular apex (LVA) in patients with preserved or mildly reduced left ventricular systolic function (\>= 45%).

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Detailed Description

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It is well established that chronic right ventricular apical pacing has an adverse effect on left ventricular systolic function. An alternative is pacing the left ventricular apex, which has shown more favourable results in terms of left ventricular pump function than the RVA in small series. The left ventricular apex may be paced via the coronary sinus tributary (e.g. in the anterior cardiac vein). Our study will compare effects of these two pacing sites on left ventricular ejection fraction measured by 3D-echocardiography.

Conditions

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Bradyarrhythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Right ventricular apex pacing

Group Type ACTIVE_COMPARATOR

Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing

Intervention Type DEVICE

Implantation procedure for a St-Jude Medical pacemaker system with a transvenous ventricular and if applicable a right atrial lead

Left ventricular apex pacing

Group Type EXPERIMENTAL

Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacing

Intervention Type DEVICE

Implantation procedure for a St-Jude Medical pacemaker system with a transvenous left ventricular (coronary sinus) and if applicable a right atrial lead

Interventions

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Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing

Implantation procedure for a St-Jude Medical pacemaker system with a transvenous ventricular and if applicable a right atrial lead

Intervention Type DEVICE

Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacing

Implantation procedure for a St-Jude Medical pacemaker system with a transvenous left ventricular (coronary sinus) and if applicable a right atrial lead

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Requirement for ventricular pacing according to current guidelines (including chronic atrial fibrillation)
* Anticipated \>=50% daily ventricular pacing
* LVEF \>=45% as evaluated by 2D-echocardiography, 3D-echocardiography, magnetic resonance imaging or by radionuclide/contrast ventriculography
* Minimum age of 18 years, and at least 1 year life expectancy

Exclusion Criteria

* Prior tricuspid valve replacement (annuloplasty is permitted)
* Intrinsic rhythm \< 30bpm
* Patients with permanent atrial fibrillation who undergo ablation of the atrioventricular node.
* Echocardiographic window of insufficient quality for measuring LVEF
* Life expectancy of \< 1year
* Pregnancy (women of childbearing potential will undergo pregnancy testing)
* Unable of unwilling to sign a patient informed consent form

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No