There is no evidence regarding the rationale behind the routine short-term use of antiarrhythmic drug (AAD) therapy after cryo-balloon ablation for symptomatic paroxysmal atrial fibrillation (PAF). We seek to better understand whether the routine use of AAD post-cryo-balloon ablation makes any difference in short- or long-term success rate in maintenance of normal sinus rhythm (NSR) for symptomatic PAF patients, monitored with an implantable loop recorder. Additionally, we propose to monitor safety related events during the entire study, while particularly examining events that occur during the 90-day blanking period.
The BIOTRONIK QP ExCELs study is a prospective, non-randomized, multi-center clinical investigation is to evaluate the safety and effectiveness of the BIOTRONIK Sentus over-the-wire (OTW) QP left ventricular (LV) lead. Male and female patients 18 years of age or older who have standard Cardiac Resynchronization Therapy Defibrillator (CRT-D) indication may be eligible to participate in this study. This clinical protocol includes a single-arm, multi-center, prospective MultiPole Pacing (MPP) sub-study to demonstrate the MPP feature is effective by converting a percentage of CRT non-responders to responders.
8 Richland Medical Park
Columbia, SC 29203
Study Site Principal Investigator Contact Information:
Sultan Siddique, MD at 803-434-3800