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

Biosense Webster

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT05752487

BWI202202 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 149 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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])

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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149 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

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