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RECRUITING
NCT07727057
NA

A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias

Sponsor: Biosense Webster, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to collect information about how safe Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) catheter with TRUPULSE™ Generator is and how effective a specific procedural workflow is when this ablation system is used to treat ventricular arrhythmias. The main aims of this study are to see whether the abnormal heart rhythm can be successfully treated while maintaining a specific procedural workflow with the catheter and generator during the cardiac ablation and to monitor participant safety after the procedure by checking if the participant has any complications.

Official title: Workflow Study of the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias (VAs)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-07-08

Completion Date

2027-09-30

Last Updated

2026-08-10

Healthy Volunteers

No

Interventions

DEVICE

Radiofrequency/Pulsed Field Ablation System

Radiofrequency and pulsed field ablation by Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) catheter with the TRUPULSE™ generator will be used.

Locations (11)

Medizinische Universitat Graz

Graz, Austria

Ordensklinikum Linz GmbH Elisabethinen

Linz, Austria

AZORG campus Aalst Moorselbaan

Aalst, Belgium

AZ Sint-Jan Brugge

Bruges, Belgium

CHU de Clermont Ferrand

Clermont-Ferrand, France

CHU de Bordeaux - Hospital Haut-Leveque

Pessac, France

RHÖN-KLINIKUM Campus Bad Neustadt

Bad Neustadt an der Saale, Germany

University Hospital of the Ruhr-University of Bochum

Bad Oeynhausen, Germany

TUM Klinikum Deutsches Herzzentrum

München, Germany

Inselspital

Bern, Switzerland

Universitatsspital Zurich

Zurich, Switzerland