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

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

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%).

Study Overview

• Status: Terminated
• Conditions: Bradyarrhythmia
• Intervention / Treatment: Device: Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing; Device: Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacing

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6229
    • Cardiovascular Research Institute, University of Maastricht
• Switzerland
  • BS
    • Basel, BS, Switzerland, 4031
      • University Hospital of Basel
  • GE
    • Geneva, GE, Switzerland, 1211
      • University Hospital Geneva
  • LU
    • Luzern, LU, Switzerland, 6000
      • Kantonsspital Luzern
  • SG
    • St-Gallen, SG, Switzerland, 9007
      • Kantonsspital St-Gallen
  • TI
    • Lugano, TI, Switzerland, 6900
      • Cardiocentro Ticino (Lugano)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Right ventricular apex pacing	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
Experimental: Left ventricular apex pacing	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in LVEF	baseline to one year

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in left ventricular end-systolic and end-diastolic volumes	one year
Dyssynchrony evaluation during RV and LV pacing	one year
Change in tricuspid regurgitation severity, if any	one year
Change in mitral regurgitation severity, if any	one year
Incidence of device-related complications	one year
Success rate of autocapture algorithm for left-and right-ventricular pacing	one year
Mortality and all cause hospitalization	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)	one year

Collaborators and Investigators

• Sponsor: Haran Burri, MD
• Collaborators: Abbott Medical Devices
• Investigators: Principal Investigator: Haran Burri, Assoc. Prof., University Hospital, Geneva; Principal Investigator: Angelo Auricchio, Prof., Fondazione Cardiocentro Ticino (Lugano); Study Chair: Christian Sticherling, Prof., University Hospital of Basel; Study Chair: Paul Erne, Prof., Luzerner Kantonsspital; Study Chair: Peter Ammann, PD Dr., Cantonal Hospital of St. Gallen; Study Chair: Frits Prinzen, Dr., Cardiovascular Research Institute, University of Maastricht

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: February 10, 2012
• First Submitted That Met QC Criteria: February 14, 2012
• First Posted (Estimate): February 17, 2012

Study Record Updates

• Last Update Posted (Estimate): May 13, 2016
• Last Update Submitted That Met QC Criteria: May 11, 2016
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: CRM-CH-Riv01