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

NCT06272981 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2025-12-10

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

Interventions

DEVICE

Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation

THERMOCOOL STSF catheter will be used in conjunction with TRUPULSE Generator to give PF ablation or 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
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-28
Primary Completion
2025-10-28
Completion
2025-10-28
FDA Device
Yes

Countries

  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT06272981 on ClinicalTrials.gov