A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)

Not Applicable

Completed

Conditions: Atrial Fibrillation

Interventions: Device: Pulsed Field Ablation (PFA) Therapy

Registration Number: NCT04524364

Lead Sponsor: Biosense Webster, Inc.

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 272

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))

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with Paroxysmal Atrial Fibrillation (PAF)	Pulsed Field Ablation (PFA) Therapy	Participants with PAF and who are candidates for catheter ablation will be enrolled.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Primary Adverse Events (PAEs)	Within 7 days post-procedure on Day 0	An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. The primary safety endpoint was the incidence of PAEs (within 7 days of the initial mapping and ablation procedure). PAEs included the following AEs: Atrio-esophageal fistula, cardiac tamponade/perforation, device or procedure related death, major vascular access complication/bleeding, myocardial infarction, pericarditis, phrenic nerve paralysis (permanent), pulmonary vein stenosis, stroke/cerebrovascular accident (CVA), thromboembolism, and transient ischemic attack (TIA).
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	From Day 91 up to Day 365 post index procedure on Day 0	Kaplan-Meier estimates of the success rate of freedom from primary effectiveness failure, that is, documented (symptomatic and asymptomatic) atrial arrhythmia (AF, AT, or AFL) recurrence based on electrocardiographic data (\>=30 seconds on arrhythmia monitoring device) from Day 91 to Day 365 post index procedure, was reported. Acute procedural failure defined as failure to confirm entrance block in all PVs except those that are silent and/or cannot be cannulated post-procedure, use of a non-study catheter for PV isolation, or failure to have PFA delivery with the study catheter due to IRE system malfunctions, was also considered a long-term effectiveness failure.

Secondary Outcome Measures

Name	Time	Method
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	From Day 91 up to Day 365 post index procedure on Day 0	Kaplan-Meier estimates of the success rate of freedom from primary effectiveness failure, that is, documented symptomatic re-occurrence of atrial arrhythmia (AF, AT, or AFL) episodes based on electrocardiographic data (\>=30 seconds on arrhythmia monitoring device) from Day 91 to Day 365 post index procedure, was reported. Acute procedural failure defined as failure to confirm entrance block in all PVs except those that are silent and/or cannot be cannulated post-procedure, use of a non-study catheter for PV isolation, or failure to have PFA delivery with the study catheter due to IRE system malfunctions, was also considered a long-term effectiveness failure.
Number of Participants Who Achieved Acute Procedural Success	Day 0 (Day of procedure)	Number of participants who achieved acute procedural success were reported. Acute procedural success was defined as confirmation of entrance block in all clinically relevant targeted pulmonary veins (PVs) after adenosine/ isoproterenol challenge.
Change From Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score	Baseline, Months 3, 6, and 12	Change from baseline in AFEQT total score was reported. The AFEQT questionnaire is an atrial fibrillation-specific health-related quality of life (HRQoL) questionnaire designed to assess the impact of atrial fibrillation on participants' HRQoL. The questionnaire includes 20 questions on a 7-point Likert scale. Questions 1-18 evaluate HRQoL and questions 19-20 relate to participants' satisfaction with treatment. Overall or subscale scores range from 0 to 100, where 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore, a positive change in score corresponds to improvement in QoL. Total score was calculated using AFEQT formula: 100 -(\[sum of severity for all questions answered - number of questions answered\]\100 / total number questions answered\6).

Trial Locations

Locations (13): Medical University Graz
🇦🇹
Graz, Austria
Jessa Ziekenhuis - Campus Virga Jesse
🇧🇪
Hasselt, Belgium
London Health Sciences Centre
🇨🇦
London, Ontario, Canada
Southlake Regional Health Centre
🇨🇦
Newmarket, Canada
University Hospital Center Split
🇭🇷
Split, Croatia
Nemocnice na Homolce
🇨🇿
Prague, Czechia
Centre Hospitalier Universitaire (CHU) de Bordeaux
🇫🇷
Bordeaux, France
Vilnius University Hospital
🇱🇹
Vilnius, Lithuania
AZ Sint-Jan Brugge
🇧🇪
Brugge, Belgium
Ordensklinikum Linz Elisabethinen
🇦🇹
Linz, Austria
OLV Aalst
🇧🇪
Aalst, Belgium
Ziekenhuis Oost-Limburg Genk Campus Sint-Jan
🇧🇪
Genk, Belgium
Ospedale Generale Regionale "F. Miulli"
🇮🇹
Acquaviva delle Fonti, Italy