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The FARAPULSE PersAFOne III Trial for the Treatment of Persistent Atrial Fibrillation | Clinical Trials | Clareo Health

COMPLETEDNA

The FARAPULSE PersAFOne III Trial for the Treatment of Persistent Atrial Fibrillation

PersAFOne III: Feasibility Study of the FARAPULSE Pulsed Field Ablation System Plus - PersAF in the Treatment of Persistent Atrial Fibrillation

NCT05272852•Boston Scientific Corporation

View on ClinicalTrials.gov

Summary

The objective of this safety and feasibility study is to assess whether the endocardial creation of electrically nonconductive lesions via PEF catheter ablation applied using the FARAPULSE Pulsed Field Ablation System Plus-PersAF is a feasible and safe treatment for PersAF and associated AFL

Detailed Description

PersAFOne III study is a prospective, multi-center safety and feasibility study in subjects with persistent AF. Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation as well as cavotricuspid isthmus interruption and other left atrial ablations at the investigator's discretion. Subjects will then be followed at 30 days, 60 ± 15 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90 day blanking period and other relevant outcome measures.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with documented drug-resistant symptomatic persistent AF meeting all three of the following criteria:
•1. Patient is refractory or intolerant to at least one Class I/III antiarrhythmic agent.
•2. ECG-documented first episode of persistent AF, lasting longer than 7 days but not longer than 365 days
•3. Holter within 90 days prior to the Enrollment Date demonstrating 24 hours of continuous AF
•2. Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
•3. Patient participation requirements:
•1. Lives locally
•2. Is willing and capable of providing Informed Consent to undergo study procedures
•3. Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study
•\-

Exclusion Criteria

•1. AF that is:
•1. Paroxysmal (longest AF episode \< 7days)
•2. Longstanding (has persisted \> 12 months or that does not respond to cardioversion if \< 12 months)
•3. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
•2. Left atrial anteroposterior diameter ≥ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
•3. Any of the following cardiac procedures, implants or conditions:
•1. Clinically significant arrhythmias other than AF, AFL or AT
•2. Hemodynamically significant valvular disease
•3. Prosthetic heart valve
•4. NYHA Class III or IV CHF
+39 more criteria

Locations (2)

Neuron Medical

Brno, Czechia

Nemocnice Na Homolce

Prague, Czechia

Key Dates

Start Date

February 3, 2022

Primary Completion Date

February 9, 2024

Completion Date

February 9, 2024

Last Updated

January 8, 2025

Enrollment

ACTUAL participants

Conditions

Persistent Atrial Fibrillation

Interventions

FARAPULSE™ Pulsed Field Ablation System Plus

DEVICE

Medtronic Terminate AF Study

NCT03546374

Persistent Atrial FibrillationLongstanding Persistent Atrial Fibrillation

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RECRUITINGNA

FIH Study of PFLotus in Persistent Atrial Fibrillation

NCT07301190

Persistent Atrial Fibrillation

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RECRUITINGNA

Hybrid Ablation of Atrial Fibrillation in Heart Failure

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The FARAPULSE PersAFOne III Trial for the Treatment of Persistent Atrial Fibrillation

Inclusion Criteria

Exclusion Criteria

Medtronic Terminate AF Study

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