Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation(PersAFOne II)

NCT05152966 | Completed Results DMC FDA Device

• 1 other identifier: CS1335
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 Cardiac Ablation System Plus is a feasible and safe treatment for PersAF and associated AFL

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs

  Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEsEndpoint(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.

  7 days

• Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs

  Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEsEndpoint(CSE) defined as the incidence of the following late-onset serious adverse events (SAEs) which are device- or procedure-related, as adjudicated by the Clinical Events and Data Monitoring Committee (CEDMC).

  12 Months

• Acute Procedural Success; Acute Vein Succes

  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

Study Arms (1)

FARAPULSE™ Endocardial Cardiac Ablation

EXPERIMENTAL

Ablation using FARAPULSE™ Cardiac Ablation System Plus

Device: Ablation

Interventions

Ablation DEVICE

Ablation using the FARAPULSE™ Cardiac Ablation System Plus

FARAPULSE™ Endocardial Cardiac Ablation

Eligibility Criteria

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

You may qualify if:

• Age 18-75 Patients with documented drug-resistant symptomatic persistent AF
• 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 3. Patient participation requirements:
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• 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 (1)

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: Christopher (Kit) Schneider
• Organization: FARAPULSE

christopher.schneider@bsci.com

6176867661

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: November 15, 2021
• First Posted: December 10, 2021
• Study Start: September 16, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 28, 2024
• Results First Posted: January 31, 2024

Record last verified: 2024-02

Locations

CZ (1)