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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation

• Registration Number: NCT05752487
• Lead Sponsor: Biosense Webster, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-02-22
• Study Start: 2023-02-27
• Study First Posted: 2023-03-02
• Primary Completion: 2023-09-25
• Study Completion: 2024-06-17
• Results First Submitted: 2024-09-23
• Results First Submitted QC: 2024-09-23
• Results First Posted: 2024-10-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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])

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Primary Adverse Events (PAEs)	90 days post-procedure on Day 1	Percentage of participants with PAEs (within 7 days following the ablation procedure) was reported. PAEs included the following adverse events atrio-esophageal fistula, pulmonary vein stenosis, device or procedure related death, (that occurred greater than 7 days and less than or equal to 90 days post-procedure), phrenic nerve paralysis (permanent), cardiac tamponade/perforation, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis.
Percentage of Participants With Acute Procedural Success	Immediately post-procedure on Day 1	Percentage of participants with acute procedural success were reported. Procedural success was defined as electrical isolation of clinically relevant targeted pulmonary veins (PVs) (confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure.

Trial Locations

Locations (9)

Medical University Graz; 🇦🇹 Graz, Austria

Ordensklinikum Linz GmbH Elisabethinen; 🇦🇹 Linz, Austria

O L V Ziekenhuis; 🇧🇪 Aalst, Belgium

Gentofte Hospital; 🇩🇰 Hellerup, Denmark

AZ Sint-Jan; 🇧🇪 Brugge, Belgium

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Vilnius University Hospital Santaros Clinics; 🇱🇹 Vilnius, Lithuania