Clinical trial NCT04524364: A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)
Official title: Pulsed Field Ablation (PFA) System for the Treatment of Paroxysmal Atrial Fibrillation (PAF) by Irreversible Electroporation (IRE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-24
Enrollment: 272
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 primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE 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)
* Selected for atrial fibrillation (AF) ablation procedure by pulmonary vein isolation (PVI)
* Failed at least one antiarrhythmic drug (AAD) (class I to IV) as evidenced by recurrent symptomatic atrial fibrillation 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:

* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
* Previous left atrium (LA) ablation or surgery
* Participant known to require ablation outside the PV region (example. cavotricuspid isthmus \[CTI\] region, 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 LA (LAD \>50 millimeter (mm) antero-posterior diameter in case of transthoracic echocardiography (TTE))

Primary outcomes:
measure: Number of Participants With Primary Adverse Events (PAEs)
timeFrame: Within 7 days post-procedure on Day 0
measure: Kaplan-Meier Estimates of the Success Rate of Freedom From Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) Episodes From Day 91 to Day 365 Post Index Procedure
timeFrame: From Day 91 up to Day 365 post index procedure on Day 0
Secondary outcomes:
measure: Number of Participants Who Achieved Acute Procedural Success
timeFrame: Day 0 (Day of procedure)
measure: Kaplan-Meier Estimates of the Success Rate of Freedom From Documented Symptomatic Re-Occurrence of Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) Episodes From Day 91 to Day 365 Post Index Procedure
timeFrame: From Day 91 up to Day 365 post index procedure on Day 0
measure: Change From Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
timeFrame: Baseline, Months 3, 6, and 12
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
city: Linz
country: Austria
facility: Ordensklinikum Linz Elisabethinen
city: Aalst
country: Belgium
facility: OLV Aalst
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg Genk Campus Sint-Jan
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis - Campus Virga Jesse
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
city: Split
country: Croatia
facility: University Hospital Center Split
city: Prague
country: Czechia
facility: Nemocnice na Homolce
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire (CHU) de Bordeaux
city: Acquaviva delle Fonti
country: Italy
facility: Ospedale Generale Regionale "F. Miulli"
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital
Study officials:
References: