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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
St. Jude Medical
Information provided by (Responsible Party):
Haran Burri, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01535404
First received: February 10, 2012
Last updated: October 19, 2014
Last verified: October 2014

February 10, 2012
October 19, 2014
January 2012
June 2015   (final data collection date for primary outcome measure)
Reduction in LVEF [ Time Frame: baseline to one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01535404 on ClinicalTrials.gov Archive Site
  • Change in left ventricular end-systolic and end-diastolic volumes [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Dyssynchrony evaluation during RV and LV pacing [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Change in tricuspid regurgitation severity, if any [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Change in mitral regurgitation severity, if any [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Incidence of device-related complications [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Success rate of autocapture algorithm for left-and right-ventricular pacing [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Mortality and all cause hospitalization [ Time Frame: one year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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%).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Bradyarrhythmia
  • 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
  • Active Comparator: Right ventricular apex pacing
    Intervention: Device: Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing
  • Experimental: Left ventricular apex pacing
    Intervention: Device: Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
190
December 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland,   Netherlands
 
NCT01535404
CRM-CH-Riv01
Yes
Haran Burri, MD, University Hospital, Geneva
Haran Burri, MD
St. Jude Medical
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
University Hospital, Geneva
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP