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

NCT06144632 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2026-01-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Biosense Webster, Inc.

    lead INDUSTRY

Principal Investigators

  • Biosense Webster Inc. Clinical Trial · Biosense Webster, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-07
Primary Completion
2025-10-30
Completion
2025-10-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06144632 on ClinicalTrials.gov