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

NCT05272852 | Completed Results DMC FDA Device

• 1 other identifier: CS1543
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint: Composite Safety Endpoint (CSE) Defined as the Incidence of the Following Early-onset and Late-onset Serious Adverse Events (SAEs) Which Are Device- or Procedure-related, as Adjudicated by the CEDMC

  Percentage of Intent to Treat subjects with one or more of the specified device or procedure related SAEs Endpoint(CSE) defined as the incidence of the following early-onset serious adverse events (SAEs) which are device- or procedure-related, as adjudicated by the Clinical Events and Data Monitoring Committee (CEDMC). Atrioesophageal fistula and PV stenosis components will be assessed for occurrence at any time during follow-up. Early onset (within 30 days of an Index or Remap Procedure) * Death * Myocardial infarction (MI) * Persistent diaphragmatic paralysis * Stroke or transient ischemic attack (TIA) * Peripheral or organ thromboembolism * Pericarditis * Cardiac tamponade / perforation * Vascular access complications requiring intervention * Heart block Late onset (any time during follow-up through 12 months) * Pulmonary vein (PV) stenosis (\> 70% diameter reduction from baseline) * Atrio-esophageal fistula

  30Days-12 months

• Primary Effectiveness Endpoint: Acute Procedural Success Acute Vein Success

  Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Cardiac Ablation System Plus during the first ablation procedure (Index or Rescheduled Index Procedure)

  Index Procedure

Secondary Outcomes (5)

• The Primary Safety Endpoint Assessed at 7 Days

  7-Days

• The Percentage of Subjects With a Device- or Procedure-related SAE

  12 Months

• The Percentage of Subjects With Stroke or TIA

  12 Months

• The Percentage of Subjects Requiring Cardioversions

  12 Months

• The Percentage of Subjects Requiring an Arrhythmia-related (AF, AFL or AT) Hospitalization

  12 Months

Study Arms (1)

FARAPULSE™ Pulsed Field Ablation System Plus

EXPERIMENTAL

Ablation using FARAPULSE™ Pulsed Field Ablation System Plus

Device: FARAPULSE™ Pulsed Field Ablation System Plus

Interventions

FARAPULSE™ Pulsed Field Ablation System Plus DEVICE

Ablation using FARAPULSE™ Pulsed Field Ablation System Plus

FARAPULSE™ Pulsed Field Ablation System Plus

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• AF that is:
• Paroxysmal (longest AF episode \< 7days)
• Longstanding (has persisted \> 12 months or that does not respond to cardioversion if \< 12 months)
• Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
• Left atrial anteroposterior diameter ≥ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
• Any of the following cardiac procedures, implants or conditions:
• Clinically significant arrhythmias other than AF, AFL or AT
• Hemodynamically significant valvular disease
• Prosthetic heart valve
• NYHA Class III or IV CHF
• Previous endocardial or epicardial ablation or surgery for AF
• Atrial or ventricular septal defect closure
• Atrial myxoma
• Left atrial appendage device or occlusion
• Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (2)

Neuron Medical

Brno, 637 00, Czechia

Location

Nemocnice Na Homolce

Prague, Czechia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Karin Froidcourt
• Organization: BostonScientific

Karin.Froidcourt@bsci.com

+0032471636566

Study Officials

• Petr Neuzil

  Nemocnice Na Homolce (homolka)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: March 10, 2022
• Study Start: February 3, 2022
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: January 8, 2025
• Results First Posted: January 8, 2025

Record last verified: 2025-01

Locations

CZ (2)