A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAFOUS - Trial NCT06272981
Access comprehensive clinical trial information for NCT06272981 through Pure Global AI's free database. This phase not specified trial is sponsored by Biosense Webster, Inc. and is currently Not yet recruiting. The study focuses on Atrial Fibrillation. Target enrollment is 135 participants.
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Study Focus
Sponsor & Location
Biosense Webster, Inc.
Timeline & Enrollment
N/A
Mar 01, 2024
Aug 29, 2025
Primary Outcome
Number of Participants with Primary Adverse Events (PAEs),Rate of Freedom from Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation (AF), Atrial Tachycardia (AT) or Atrial Flutter (AFL) of Unknown Origin) within 91-365 Days Post Index Procedure
Summary
The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster
 (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow [STSF] catheter and TRUPULSE
 generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of
 participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing
 abnormal blood flow.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06272981
Device Trial