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
  Purpose

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%).


Condition Intervention
Bradyarrhythmia
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function (RIVELA) Study

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Reduction in LVEF [ Time Frame: baseline to one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 190
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535404

Locations
Netherlands
Cardiovascular Research Institute, University of Maastricht
Maastricht, Netherlands, 6229
Switzerland
University Hospital of Basel
Basel, BS, Switzerland, 4031
University Hospital Geneva
Geneva, GE, Switzerland, 1211
Kantonsspital Luzern
Luzern, LU, Switzerland, 6000
Kantonsspital St-Gallen
St-Gallen, SG, Switzerland, 9007
Cardiocentro Ticino (Lugano)
Lugano, TI, Switzerland, 6900
Sponsors and Collaborators
Haran Burri, MD
St. Jude Medical
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
  More Information

No publications provided

Responsible Party: Haran Burri, MD, Assoc. Prof., University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01535404     History of Changes
Other Study ID Numbers: CRM-CH-Riv01
Study First Received: February 10, 2012
Last Updated: October 19, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014