Monitoring Safety and Recurrence of Paroxysmal Atrial Fibrillation after 1st cryo-balloon ablation with and without antiarrhythmic drug therapy during the 90-day blanking period ? examined with adverse event monitoring and Implantable Loop Recorder Save

Date Added
November 4th, 2016
PRO Number
Pro00055684
Researcher
Sultan Siddique
Keywords
Heart
Summary

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.

Institution
Palmetto
Recruitment Contact
Michele Neese
803-434-7614
michele.neese@palmettohealth.org

BIOTRONIK, Inc. Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads Save

Date Added
October 25th, 2016
PRO Number
Pro00056102
Researcher
Sultan Siddique
Keywords
Cardiovascular, Heart, Surgery
Summary

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.

Study Site:
Palmetto Heart
8 Richland Medical Park
Columbia, SC 29203

Study Site Principal Investigator Contact Information:
Sultan Siddique, MD at 803-434-3800

Institution
Palmetto
Recruitment Contact
Sultan Siddique
803-434-3800
ClinicalTrialSurvey@PalmettoHealth.org

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