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

Primary Purpose

Bradyarrhythmia

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing
Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacing
Sponsored by
Haran Burri, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bradyarrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiovascular Research Institute, University of Maastricht
  • University Hospital of Basel
  • University Hospital Geneva
  • Kantonsspital Luzern
  • Kantonsspital St-Gallen
  • Cardiocentro Ticino (Lugano)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Right ventricular apex pacing

Left ventricular apex pacing

Arm Description

Outcomes

Primary Outcome Measures

Reduction in LVEF

Secondary Outcome Measures

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

Full Information

First Posted
February 10, 2012
Last Updated
May 11, 2016
Sponsor
Haran Burri, MD
Collaborators
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01535404
Brief Title
Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function Study
Acronym
RIVELA
Official Title
Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function (RIVELA) Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Haran Burri, MD
Collaborators
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradyarrhythmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Right ventricular apex pacing
Arm Type
Active Comparator
Arm Title
Left ventricular apex pacing
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing
Intervention Description
Implantation procedure for a St-Jude Medical pacemaker system with a transvenous ventricular and if applicable a right atrial lead
Intervention Type
Device
Intervention Name(s)
Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacing
Intervention Description
Implantation procedure for a St-Jude Medical pacemaker system with a transvenous left ventricular (coronary sinus) and if applicable a right atrial lead
Primary Outcome Measure Information:
Title
Reduction in LVEF
Time Frame
baseline to one year
Secondary Outcome Measure Information:
Title
Change in left ventricular end-systolic and end-diastolic volumes
Time Frame
one year
Title
Dyssynchrony evaluation during RV and LV pacing
Time Frame
one year
Title
Change in tricuspid regurgitation severity, if any
Time Frame
one year
Title
Change in mitral regurgitation severity, if any
Time Frame
one year
Title
Incidence of device-related complications
Time Frame
one year
Title
Success rate of autocapture algorithm for left-and right-ventricular pacing
Time Frame
one year
Title
Mortality and all cause hospitalization
Time Frame
one year
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haran Burri, Assoc. Prof.
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angelo Auricchio, Prof.
Organizational Affiliation
Fondazione Cardiocentro Ticino (Lugano)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian Sticherling, Prof.
Organizational Affiliation
University Hospital of Basel
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Paul Erne, Prof.
Organizational Affiliation
Luzerner Kantonsspital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peter Ammann, PD Dr.
Organizational Affiliation
Cantonal Hospital of St. Gallen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Frits Prinzen, Dr.
Organizational Affiliation
Cardiovascular Research Institute, University of Maastricht
Official's Role
Study Chair
Facility Information:
Facility Name
Cardiovascular Research Institute, University of Maastricht
City
Maastricht
ZIP/Postal Code
6229
Country
Netherlands
Facility Name
University Hospital of Basel
City
Basel
State/Province
BS
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
University Hospital Geneva
City
Geneva
State/Province
GE
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Kantonsspital Luzern
City
Luzern
State/Province
LU
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Kantonsspital St-Gallen
City
St-Gallen
State/Province
SG
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Cardiocentro Ticino (Lugano)
City
Lugano
State/Province
TI
ZIP/Postal Code
6900
Country
Switzerland

12. IPD Sharing Statement

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

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