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

Overview

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 Title of Study: “Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function (RIVELA) Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2016

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Right ventricular apex pacing
  • Experimental: Left ventricular apex pacing

Clinical Trial Outcome Measures

Primary Measures

  • Reduction in LVEF
    • Time Frame: baseline to one year

Secondary Measures

  • Change in left ventricular end-systolic and end-diastolic volumes
    • Time Frame: one year
  • Dyssynchrony evaluation during RV and LV pacing
    • Time Frame: one year
  • Change in tricuspid regurgitation severity, if any
    • Time Frame: one year
  • Change in mitral regurgitation severity, if any
    • Time Frame: one year
  • Incidence of device-related complications
    • Time Frame: one year
  • Success rate of autocapture algorithm for left-and right-ventricular pacing
    • Time Frame: one year
  • Mortality and all cause hospitalization
    • Time Frame: one year
  • Reduction of LVEF at 1 year compared to baseline according to the following pre-specified subgroups: a) initial LVEF, b) gender, c)etiology (coronary artery disease, nonischemic cardiomyopathy)
    • Time Frame: one year

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Haran Burri, MD
  • Collaborator
    • Abbott Medical Devices
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Haran Burri, MD, Assoc. Prof. – University Hospital, Geneva
  • Overall Official(s)
    • Haran Burri, Assoc. Prof., Principal Investigator, University Hospital, Geneva
    • Angelo Auricchio, Prof., Principal Investigator, Fondazione Cardiocentro Ticino (Lugano)
    • Christian Sticherling, Prof., Study Chair, University Hospital of Basel
    • Paul Erne, Prof., Study Chair, Luzerner Kantonsspital
    • Peter Ammann, PD Dr., Study Chair, Cantonal Hospital of St. Gallen
    • Frits Prinzen, Dr., Study Chair, Cardiovascular Research Institute, University of Maastricht

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.