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

Haran Burri, MD

Status: Terminated

Conditions: Bradyarrhythmia

Treatments: Device: Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacing; Device: Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01535404

CRM-CH-Riv01

Details and patient eligibility

About

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%).

Full description

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Right ventricular apex pacing

Active Comparator group

Treatment:

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

Left ventricular apex pacing

Experimental group

Treatment:

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