A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator

NCT ID: NCT05752487

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-27
• Study Completion Date: 2024-06-17

Brief Summary

The purpose of this study is to demonstrate safety and effectiveness of the ablation system (THERMOCOOL SMARTTOUCH SF [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Participants with drug refractory, paroxysmal atrial fibrillation (PAF) who are candidates for catheter ablation will be enrolled with ablation system which uses THERMOCOOL SMARTTOUCH SF (STSF) catheter and TRUPULSE generator to deliver RF or PF energy during cardiac ablation procedures.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Participants will undergo catheter ablation with the PF /RF ablation system consisting of the TRUPULSE Generator (delivers RF or PF energy through the study catheter) and the THERMOCOOL SMARTTOUCH SF (STSF) Catheter (indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a Generator, for cardiac ablation).

Interventions

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

Participants will undergo catheter ablation with the PF /RF ablation system consisting of the TRUPULSE Generator (delivers RF or PF energy through the study catheter) and the THERMOCOOL SMARTTOUCH SF (STSF) Catheter (indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a Generator, for cardiac ablation).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) defined as atrial fibrillation (AF) that terminates spontaneously or with intervention within 7 days of onset. This PAF is considered to be symptomatic if symptoms related to AF are experienced by the participant
• Selected for AF ablation procedure by pulmonary vein isolation (PVI)
• Failed at least one antiarrhythmic drug (AAD) (class I to IV) as evidenced by recurrent symptomatic AF, or intolerable or contraindicated to the AAD
• Willing and capable of providing consent
• Able and willing to comply with all pre-, post- and follow-up testing and requirements.

Exclusion Criteria

• Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity {Body Mass Index greater than [>] 40 kilograms per meter square [kg/m²]}, renal insufficiency (with an estimated creatinine clearance less than [<] 30 milliliters [mL]/ minute [min]/1.73 meter square [m2] )
• Previous left atrium (LA) ablation or surgery
• Patients known to require ablation outside the pulmonary vein (PV) region (example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, ventricular tachycardia and wolff-parkinson-white)
• Previously diagnosed with persistent AF [greater than (>) 7 days in duration]
• Severe dilatation of the left atrium (LA) (Left anterior descending artery [LAD] >50mm antero-posterior diameter in case of Transthoracic Echocardiography [TTE])

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Biosense Webster, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Biosense Webster, Inc.

Locations

Medical University Graz

Graz, , Austria

Ordensklinikum Linz GmbH Elisabethinen

Linz, , Austria

O L V Ziekenhuis

Aalst, , Belgium

AZ Sint-Jan

Bruges, , Belgium

Ziekenhuis Oost-Limburg

Genk, , Belgium

Jessa Ziekenhuis

Hasselt, , Belgium

Aarhus University Hospital

Aarhus, , Denmark

Gentofte Hospital

Hellerup, , Denmark

Vilnius University Hospital Santaros Clinics

Vilnius, , Lithuania

Countries

Austria; Belgium; Denmark; Lithuania

References

De Potter T, Scherr D, Purerfellner H, Rackauskas G, Hansen J, Vijgen J, Phlips T, Knecht S, Szeplaki G, Van Herendael H, Kronborg MB, Berte B, Ruwald M, Kollias G, Lukac P, Tan T, Duytschaever M. Dual energy for pulmonary vein isolation using focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 12-month results. Europace. 2025 Sep 1;27(9):euaf174. doi: 10.1093/europace/euaf174.

Reference Type: DERIVED

PMID: 40796332 (View on PubMed)

Duytschaever M, Rackauskas G, De Potter T, Hansen J, Knecht S, Phlips T, Vijgen J, Scherr D, Szeplaki G, Van Herendael H, Kronborg MB, Berte B, Purerfellner H, Lukac P. Dual energy for pulmonary vein isolation using dual-energy focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 3-month results. Europace. 2024 May 2;26(5):euae088. doi: 10.1093/europace/euae088.

Reference Type: DERIVED

PMID: 38696675 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BWI202202

Identifier Type: OTHER

Identifier Source: secondary_id

BWI202202

Identifier Type: -

Identifier Source: org_study_id