Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Left Ventricular Pacing to Prevent Iatrogenic Tricuspid Regurgitation Caused by Conventional Right Ventricular Pacing: a Pilot Study
Brief Summary:
Background and Aims Pacemaker implantation for treating bradyarrhythmias typically involves placing a pacing lead through the tricuspid valve (TV) into the right ventricular (RV) apex. It is now known that tricuspid regurgitation (TR) frequently results from this and may lead to increased morbidity or mortality. Recently, left ventricular (LV) pacing through an epicardial vein via the coronary sinus has been widely practiced due to the advent of biventricular pacing. This lead does not cross the TV, potentially reducing the risk of TV dysfunction and may also reduce the risk of LV dysfunction. The investigators hypothesize that LV pacing will prevent the onset of new TR or worsening of pre-existing TR in patients undergoing pacemaker implantation.
Methods Patients receiving a pacemaker for sick sinus syndrome (n=20) with an LV ejection fraction <40% will be randomly allocated to receive either conventional RV pacing or LV pacing via the coronary sinus. Serial 2D and 3D transthoracic echocardiography will be performed before implantation, one day post implantation, then at 1 week, 1 month, 6 months and 1 year. The primary endpoints will be new onset TR and the diagnosis of at least moderate TR. Other endpoints include biventricular function, ventricular dyssynchrony, complications of device implantation, mortality and major cardiovascular events.