A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
NCT07727057 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-08-10
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.
Conditions
- Arrhythmias, Cardiac
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.
Sponsors & Collaborators
-
Biosense Webster, Inc.
lead INDUSTRY
Principal Investigators
-
Johnson & Johnson Medical Clinical Trial · Johnson & Johnson K.K. Medical Company
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-08
- Primary Completion
- 2027-09-30
- Completion
- 2027-09-30
- FDA Device
- Yes
Countries
- Austria
- Belgium
- France
- Germany
- Switzerland
Study Locations
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