NCT01535404

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Haran Burri, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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%).

Detailed 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.

Conditions

• Bradyarrhythmia

Interventions

Type	Name	Description
DEVICE	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
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

Timeline

• Start date: 2012-01-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2012-02-17
• Last updated: 2016-05-13

Locations

6 sites across 2 countries: Netherlands, Switzerland