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Not Yet Recruiting NCT05752487

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

Conditions: Atrial Fibrillation

Sex: All
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 135
Sponsor: Biosense Webster, Inc.

Location: Austria

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).

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 participantSelected 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 AADWilling and capable of providing consentAble 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 surgeryPatients 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])

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05752487). StuddyBuddy aggregates publicly available trial information.