Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function Study (RIVELA)
This study is currently recruiting participants.
Verified February 2012 by University Hospital, Geneva
Sponsor:
Haran Burri, MD
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: February 14, 2012
Last verified: February 2012
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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 2014 |
| Estimated Primary Completion Date: | June 2014 (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 to 80 Years |
| 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
- Age 18-80 years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535404
Contacts
| Contact: Haran Burri, Assoc. Prof. | +41 (0)22 309 45 45 | Haran.Burri@hcuge.ch |
| Contact: Angelo Auricchio, Prof. | +41 (0)91 805 31 66 | Angelo.Auricchio@cardiocentro.org |
Locations
| Netherlands | |
| Cardiovascular Research Institute, University of Maastricht | Not yet recruiting |
| Maastricht, Netherlands, 6229 | |
| Contact: Frits Prinzen, Dr. +31 43 388 10 80 frits.prinzen@maastrichtuniversity.nl | |
| Switzerland | |
| University Hospital of Basel | Not yet recruiting |
| Basel, BS, Switzerland, 4031 | |
| Contact: Christian Sticherling, Prof. +41 (0)61 265 55 26 csticherling@uhbs.ch | |
| University Hospital Geneva | Recruiting |
| Geneva, GE, Switzerland, 1211 | |
| Contact: Haran Burri, Assoc. Prof. +41 (0)22 309 45 45 Haran.Burri@Hcuge.ch | |
| Kantonsspital Luzern | Not yet recruiting |
| Luzern, LU, Switzerland, 6000 | |
| Contact: Paul Erne, Prof. +41 (0)41 205 52 08 paul.erne@ksl.ch | |
| Kantonsspital St-Gallen | Not yet recruiting |
| St-Gallen, SG, Switzerland, 9007 | |
| Contact: Peter Ammann, Dr. +41 (0)71 494 11 11 peter.ammann@kssg.ch | |
| Cardiocentro Ticino (Lugano) | Not yet recruiting |
| Lugano, TI, Switzerland, 6900 | |
| Contact: Angelo Auricchio, Prof. +41 (0)91 805 31 66 Angelo.Auricchio@cardiocentro.org | |
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. | Kantonsspital 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: | February 14, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Additional relevant MeSH terms:
|
Bradycardia Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013