PEFCATII Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation

NCT04170608 | Completed Results DMC FDA Device

• 1 other identifier: CS0571
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 2

Brief Summary

PEFCAT II: Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Safety: Number of Participants With Prespecified Primary Safety Events Within 30 Days of Index Procedure.

  Number of patients with death, MI, diaphragmatic paralysis, stroke/TIA, thromboemolism, pericarditis, tamponade/perforation, vascular access complications, hospitalization, heart block, PV stenosis, atrioesophageal fistula.

  30 Days

• Feasibility: Acute Key Procedural Success

  The primary feasibility endpoint for this study is the proportion of subjects that achieve Acute Procedural Success (APS) defined as the percutaneous endocardial creation of a complete, electrically isolating set of lesions around the ostia of the pulmonary veins (PVI) using the FARAPULSE Endocardial Multi Ablation System during the first Procedure, as clinically assessed by entrance and/or exit block performed ≥ 20 minutes after the last PVI lesion is made.

  Index Procedure

Study Arms (1)

FARAPULSE Endocardial Ablation

EXPERIMENTAL

Ablation using the FARAPULSE Endocardial Multi Ablation System

Device: FARAPULSE Endocardial Multi Ablation System

Interventions

FARAPULSE Endocardial Multi Ablation System DEVICE

Ablation using the FARAPULSE Endocardial Multi Ablation System

FARAPULSE Endocardial 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:

• Patients with documented drug-resistant symptomatic PAF meeting all three of the following criteria:
• Confirmed AF: Documentation must include a recording such as ECG, transtelephonic monitor (TTM), Holter monitor, implanted devices, or telemetry strip, recorded within one year prior to enrollment and showing at least 30 seconds of AF.
• Frequent AF, defined as ≥ 2 episodes within 6 months of enrollment.
• Failed atrial fibrillation drug (AFD) treatment, meaning therapeutic failure of at least one AFD (class I - IV) for efficacy and / or intolerance.
• 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:

• Atrial fibrillation that is any of the following:
• Persistent (by diagnosis or duration \> 7 days)
• Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
• Requires ≥ 4 cardioversions in the preceding 12 months
• Left atrial anteroposterior diameter ≥ 5.0 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)

University Hospital of Split

Split, 21000, Croatia

Location

Nemocnice Na Homolce

Prague, Czechia

Location

Related Publications (1)

• Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H, Minami K, Breskovic T, Sikiric I, Sediva L, Chovanec M, Koruth J, Jais P. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.

  PMID: 33933412 DERIVED

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 Schneider
• Organization: FARAPULSE

kschneider@farapulse.com

617-686-7661

Study Officials

• Petr Neuzil

  Nemocnice Na Homolce

  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: October 17, 2019
• First Posted: November 20, 2019
• Study Start: October 18, 2019
• Primary Completion: December 7, 2020
• Study Completion: December 7, 2020
• Last Updated: May 4, 2022
• Results First Posted: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1); CZ (1)