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NOT YET RECRUITING
NCT07845682
NA

A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With TRUPULSE™ Generator in Persistent Atrial Fibrillation

Sponsor: Biosense Webster, Inc.

View on ClinicalTrials.gov

Summary

This purpose of this study is to understand how safe Biosense Webster Pulsed Field (PF)/Radiofrequency (RF) ablation system is and how well it works over 12 months in participants with persistent atrial fibrillation (PsAF; abnormal heart signals that cause irregular heartbeats).

Official title: A Prospective, Multicenter, Single Arm With Performance Goal Study to Evaluate Safety and Effectiveness of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator in Persistent Atrial Fibrillation (PsAF)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-09-24

Completion Date

2028-04-17

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

DEVICE

Radiofrequency/Pulsed Field Ablation

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