Clinical trial NCT01535404: Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function Study
Official title: Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function (RIVELA) Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bradyarrhythmia
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2012-02-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction in LVEF
timeFrame: baseline to one year
Secondary outcomes:
measure: Change in left ventricular end-systolic and end-diastolic volumes
timeFrame: one year
measure: Dyssynchrony evaluation during RV and LV pacing
timeFrame: one year
measure: Change in tricuspid regurgitation severity, if any
timeFrame: one year
measure: Change in mitral regurgitation severity, if any
timeFrame: one year
measure: Incidence of device-related complications
timeFrame: one year
measure: Success rate of autocapture algorithm for left-and right-ventricular pacing
timeFrame: one year
measure: Mortality and all cause hospitalization
timeFrame: one year
measure: 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)
timeFrame: one year
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Cardiovascular Research Institute, University of Maastricht
city: Basel
country: Switzerland
facility: University Hospital of Basel
state: BS
city: Geneva
country: Switzerland
facility: University Hospital Geneva
state: GE
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
state: LU
city: St-Gallen
country: Switzerland
facility: Kantonsspital St-Gallen
state: SG
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino (Lugano)
state: TI
Study officials:
affiliation: University Hospital, Geneva
name: Haran Burri, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Cardiocentro Ticino (Lugano)
name: Angelo Auricchio, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Basel
name: Christian Sticherling, Prof.
role: STUDY_CHAIR
affiliation: Luzerner Kantonsspital
name: Paul Erne, Prof.
role: STUDY_CHAIR
affiliation: Cantonal Hospital of St. Gallen
name: Peter Ammann, PD Dr.
role: STUDY_CHAIR
affiliation: Cardiovascular Research Institute, University of Maastricht
name: Frits Prinzen, Dr.
role: STUDY_CHAIR
References: