Clinical trial NCT05752487: A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator
Official title: Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-02
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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 \[TTE\])

Primary outcomes:
measure: Percentage of Participants With Primary Adverse Events (PAEs)
timeFrame: 90 days post-procedure on Day 1
measure: Percentage of Participants With Acute Procedural Success
timeFrame: Immediately post-procedure on Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen
city: Aalst
country: Belgium
facility: O L V Ziekenhuis
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Clinics
Study officials:
affiliation: Biosense Webster, Inc.
name: Biosense Webster, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: