CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 237 enrolled
Drug / intervention
THERMOCOOL STSF Bi- Directional Navigation Catheter +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06144632
NCT06144632N/ACompleted
CompareCT.gov

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.·interventional·Posted Nov 22, 2023·Updated Jan 16, 2026

In Brief

A clinical study evaluating THERMOCOOL STSF Bi- Directional Navigation Catheter and TRUPULSE Generator for Drug Refractory Paroxysmal Atrial Fibrillation. Completed, enrolled 237 participants across 29 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDrug Refractory Paroxysmal Atrial Fibrillation
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedNov 22, 2023
Enrollment StartDec 7, 2023
Primary CompletionOct 30, 2025
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 2.6 years ago

Interventions

THERMOCOOL STSF Bi- Directional Navigation Catheterdevice

THERMOCOOL STSF will be used in conjunction with TRUPULSE Generator to give pulsed field (PF) ablation or radiofrequency (RF) ablation.

TRUPULSE Generatordevice

TRUPULSE Generator will be used to deliver PF/RF ablation.