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COMPLETED
NCT06272981
NA

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

Sponsor: Biosense Webster, Inc.

View on ClinicalTrials.gov

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.

Official title: Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation (PAF)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2024-02-28

Completion Date

2025-10-28

Last Updated

2026-10-16

Healthy Volunteers

No

Interventions

DEVICE

Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation

THERMOCOOL STSF catheter will be used in conjunction with TRUPULSE Generator to give PF ablation or RF ablation.

Locations (7)

Royal Prince Alfred Hospital

Camperdown, Australia

Canberra Heart Rhythm

Garran, Australia

Westmead Hospital

Westmead, Australia

Southlake Regional Health Centre

Newmarket, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada