CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 149 enrolled
Drug / intervention
Pulsed Field (PF) /Radiofrequency (RF) Catheter ablationdevice
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/NCT05752487
NCT05752487N/ACompleted
CompareCT.gov

Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)

Biosense Webster, Inc.·interventional·Posted Mar 2, 2023·Updated Jul 1, 2025

In Brief

A clinical study evaluating Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation for Atrial Fibrillation. Completed, enrolled 149 participants across 9 sites in 4 countries.

Detailed Summary

The purpose of this study is to demonstrate safety and effectiveness of the ablation system (THERMOCOOL SMARTTOUCH SF \[STSF\] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesAustria, Belgium, Denmark, Lithuania
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedMar 2, 2023
Enrollment StartFeb 27, 2023
Primary CompletionSep 25, 2023
Study CompletionJun 17, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.3 years ago

Interventions

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

Participants will undergo catheter ablation with the PF /RF ablation system consisting of the TRUPULSE Generator (delivers RF or PF energy through the study catheter) and the THERMOCOOL SMARTTOUCH SF (STSF) Catheter (indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a Generator, for cardiac ablation).