NCT06144632

A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAF

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: Biosense Webster, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Drug Refractory Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	THERMOCOOL STSF Bi- Directional Navigation Catheter	THERMOCOOL STSF will be used in conjunction with TRUPULSE Generator to give pulsed field (PF) ablation or radiofrequency (RF) ablation.
DEVICE	TRUPULSE Generator	TRUPULSE Generator will be used to deliver PF/RF ablation.

Timeline

• Start date: 2023-12-07
• Primary completion: 2025-10-30
• Completion: 2025-10-30
• First posted: 2023-11-22
• Last updated: 2026-01-16

Locations

29 sites across 1 country: United States

Regulatory

• FDA-regulated device study