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NCT06272981Not yet recruiting

A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAFOUS

Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation (PAF)
Biosense Webster, Inc.ClinicalTrials.govdeviceDevice trial
Verified
Study focus
Disease/Condition
Atrial Fibrillation
Drug/Device/Intervention
Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Biosense Webster, Inc.
Location
Camperdown,Garran,New Lambton Heights,Westmead,Newmarket,Ottawa,Montreal,Montreal, Australia,Canada
Timeline & enrollment
Phase
N/A
Start date
Mar 01, 2024
End date
Aug 29, 2025
Enrollment
135 participants
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
Chronic atrial fibrillationPersistent atrial fibrillationParoxysmal atrial fibrillationAtrial fibrillation and flutterAtrial fibrillation and atrial flutter, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06272981
Type
Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.