Bradyarrhythmia
Conditions
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.
Interventions
DEVICEImplantation 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
DEVICEImplantation 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
Sponsors
Abbott Medical Devices
Haran Burri, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in LVEF | baseline to one year |
Secondary
| Measure | Time frame |
|---|---|
| Dyssynchrony evaluation during RV and LV pacing | one year |
| Change in tricuspid regurgitation severity, if any | one year |
| Change in mitral regurgitation severity, if any | one year |
| Change in left ventricular end-systolic and end-diastolic volumes | one year |
| Success rate of autocapture algorithm for left-and right-ventricular pacing | one year |
| Mortality and all cause hospitalization | one year |
| 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 |
| Incidence of device-related complications | one year |
Countries
Netherlands, Switzerland
Outcome results
None listed