Bradyarrhythmia Clinical Trial
— RIVELAOfficial title:
Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function (RIVELA) Study
Verified date | October 2014 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Interventional |
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%).
Status | Terminated |
Enrollment | 36 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Cardiovascular Research Institute, University of Maastricht | Maastricht | |
Switzerland | University Hospital of Basel | Basel | BS |
Switzerland | University Hospital Geneva | Geneva | GE |
Switzerland | Cardiocentro Ticino (Lugano) | Lugano | TI |
Switzerland | Kantonsspital Luzern | Luzern | LU |
Switzerland | Kantonsspital St-Gallen | St-Gallen | SG |
Lead Sponsor | Collaborator |
---|---|
Haran Burri, MD | St. Jude Medical |
Netherlands, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in LVEF | baseline to one year | No | |
Secondary | Change in left ventricular end-systolic and end-diastolic volumes | one year | No | |
Secondary | Dyssynchrony evaluation during RV and LV pacing | one year | No | |
Secondary | Change in tricuspid regurgitation severity, if any | one year | No | |
Secondary | Change in mitral regurgitation severity, if any | one year | No | |
Secondary | Incidence of device-related complications | one year | Yes | |
Secondary | Success rate of autocapture algorithm for left-and right-ventricular pacing | one year | Yes | |
Secondary | Mortality and all cause hospitalization | one year | No | |
Secondary | 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) | one year | No |
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