A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation

NCT03714178 | Completed Results DMC FDA Device

• 1 other identifier: CS0267
• Study Type: interventional
• Target: 71
• Locations: 2 countries
• Sites: 2

Brief Summary

PEFCAT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the FARAPULSE Endocardial Ablation System for the treatment of paroxysmal atrial fibrillation.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• The Primary Safety Endpoint for This Study is the Composite Safety Endpoint (CSE) Defined as the Proportion of Patients With Early-onset and Late-onset Serious Adverse Events (SAEs) Which Are Device- or Procedure-related.

  Early onset (within 30 days of any endocardial ablation for atrial fibrillation). Occurrence of any one of the below events will qualify a subject as a safety failure. * Death * Myocardial infarction (MI) * Persistent diaphragmatic paralysis * Stroke or transient ischemic attack (TIA) * Peripheral or organ thromboembolism * Pericarditis * Cardiac tamponade / perforation * Vascular access complications * Hospitalization (initial or prolonged)\* * Heart block * Late onset (any time during follow-up) * Pulmonary vein (PV) stenosis (\> 70% diameter reduction from baseline) * Atrio-esophageal fistula \* Excludes hospitalization (initial \& prolonged) solely due to arrhythmia (AF/Atrial Flutter/Atrial Tachycardia) recurrence or due to non-urgent cardioversion (pharmacological or electrical).

  30 days~12 Months

Secondary Outcomes (1)

• Feasibility: Pulmonary Vein Isolation

  1 Day (Acute)

Study Arms (1)

FARAPULSE Endocardial Ablation

EXPERIMENTAL

Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation.

Device: FARAPULSE Endocardial Ablation System

Interventions

FARAPULSE Endocardial Ablation System DEVICE

Endocardial ablation using the FARAPULSE Endocardial 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 who have:
• Confirmed AF: Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor, implanted devices, telemetry strip or similar, 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 AFD, meaning therapeutic failure of at least one antiarrhythmic drug (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:

• Use of amiodarone within 3 months prior to enrollment
• 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 ≥ 3 cardioversions in the preceding 12 months
• Left atrial anteroposterior diameter ≥ 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
• Left ventricular ejection fraction ≤ 40% as documented by TTE
• Any of the following cardiac procedures, implants or conditions:
• Clinically significant arrhythmias other than AF
• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (2)

Nemocnice Na Homolce

Prague, Czechia

Location

CHU Bordeaux

Pessac, France

Location

Related Publications (1)

• Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati SR, Jais P. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. J Am Coll Cardiol. 2019 Jul 23;74(3):315-326. doi: 10.1016/j.jacc.2019.04.021. Epub 2019 May 11.

  PMID: 31085321 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: Kit Schneider
• Organization: Farapulse

kschnieder@farapulse.com

617-686-7661

Study Officials

• Petr Neuzil, MD, PhD

  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

Model Details: Patients undergoing catheter ablation of paroxysmal atrial fibrillation and meeting all protocol inclusion/exclusion criteria will be treated with the FARAPULSE Endocardial Ablation System.

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 22, 2018
• Study Start: October 20, 2018
• Primary Completion: December 21, 2020
• Study Completion: December 21, 2020
• Last Updated: May 4, 2022
• Results First Posted: May 4, 2022

Record last verified: 2022-05

Locations

CZ (1); FR (1)