Sinus-node Dysfunction Clinical Trial
Official title:
Right Ventricular Outflow Tract Septal Pacing for Cardiac Dysfunction Prevention Evaluation
This is a prospective, randomized, double blinded, multi-center, controlled study to evaluate the clinical impact at 18 months after DDD implantation of alternative pacing site (RVOTs and RVA) and the different conduction path (RVOTs and AV node) on cardiac dysfunction prevention.
Ventricular pacing is unavoidable in many patients because of unreliable or absent AV
conduction, or permanent AF. In recognition of this need, interest has focused on alternative
site(s) ventricular pacing to maximize pumping function. These sites include the RV septum,
His bundle, various LV sites, and combination of LV and RV (biventricular [BiV]). The RV
outflow tract septum (RVOTs) seems to be the most promising site within the RV.
However, small enrollment and inconsistent experimental methods hinder the interpretation of
these studies. Locations of alternative pacing sites were not clearly specified, were largely
topographic, and lacked consistent anatomic designation. And what is more, there was no
prospective, double-blind randomized, multi-center clinical trial which is design to test
whether RVOTs pacing is superior to right ventricular apical pacing in preserving left
ventricular systolic function and avoiding adverse left ventricular remodeling in patients
with a normal left ventricular ejection fraction, ventricular synchrony and standard
indications for pacing (sinus node dysfunction) in China. There was also no prospective,
double-blind randomized, multi-center clinical trial which is design to test whether RVOTs
pacing is not inferior to AAIR pacing in preserving left ventricular systolic function and
avoiding adverse left ventricular remodeling in patients with a normal left ventricular
ejection fraction, ventricular synchrony and sinus node dysfunction in the world.
So SJM China will sponsor a prospective, randomized, double blinded, multi-center, controlled
study to evaluate the clinical impact at 18 months after DDD implantation of alternative
pacing site (RVOTs and RVA) and the different conduction path (RVOTs and AV node) on cardiac
dysfunction prevention.
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