N/A N=272 Treatment

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

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT04524364 ↗

Enrolled (actual)

272

Serious AEs

5.5%

Results posted

May 2024

Primary outcome: Primary: Number of Participants With Primary Adverse Events (PAEs) — 0; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Pulsed Field Ablation (PFA) Therapy (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Biosense Webster, Inc.
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Primary Adverse Events (PAEs)	0; 0; 0	—
PRIMARY 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	71.8; 75.6; 80.0	—
SECONDARY Number of Participants Who Achieved Acute Procedural Success	40; 186; 30	—
SECONDARY 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	76.9; 81.7; 80.0	—
SECONDARY Change From Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score	27.38; 23.02; 26.03; 28.21; 25.06; 24.77	—

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))

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Data sourced from ClinicalTrials.gov (NCT04524364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.