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

• ClinicalTrials.gov Identifier: NCT03714178
• Recruitment Status: Completed
• First Posted: October 22, 2018
• Results First Posted: May 4, 2022
• Last Update Posted: May 4, 2022
• Sponsor: Farapulse, Inc.
• Information provided by (Responsible Party): Farapulse, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Paroxysmal Atrial Fibrillation	Device: FARAPULSE Endocardial Ablation System	Not Applicable

Detailed Description:

Patients undergoing catheter ablation for paroxysmal atrial fibrillation will be screened for enrollment per protocol inclusion and exclusion criteria. Enrolled patients will then undergo ablation using the FARAPULSE Endocardial Ablation System. Subjects will be followed at 7 days, 30 days, 75 days, 6 months, and 12 months with a blanking period for recurrent atrial fibrillation or atrial tachycardia of 3 months following the PEF (pulsed electric field) catheter ablation procedure.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 71 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Patients undergoing catheter ablation of paroxysmal atrial fibrillation and meeting all protocol inclusion/exclusion criteria will be treated with the FARAPULSE Endocardial Ablation System.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: PEFCAT: A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation
• Actual Study Start Date: October 20, 2018
• Actual Primary Completion Date: December 21, 2020
• Actual Study Completion Date: December 21, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: FARAPULSE Endocardial Ablation; Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation.	Device: FARAPULSE Endocardial Ablation System; Endocardial ablation using the FARAPULSE Endocardial Ablation System.

Outcome Measures

Primary Outcome Measures :

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. [ Time Frame: 30 days~12 Months ]

   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).

Secondary Outcome Measures :

1. Feasibility: Pulmonary Vein Isolation [ Time Frame: 1 Day (Acute) ]
   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 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Patients with documented drug resistant symptomatic PAF who have:

   1. 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.
   2. Frequent AF, defined as ≥ 2 episodes within 6 months of enrollment.
   3. Failed AFD, meaning therapeutic failure of at least one antiarrhythmic drug (AFD; class I - IV) for efficacy and / or intolerance
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. Use of amiodarone within 3 months prior to enrollment

2. Atrial fibrillation that is any of the following

   1. Persistent (by diagnosis or duration > 7 days)
   2. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
   3. Requires ≥ 3 cardioversions in the preceding 12 months

3. Cardiac anatomical exclusions by imaging within 3 months prior to enrollment:

   1. Left atrial anteroposterior diameter ≥ 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
   2. Left ventricular ejection fraction ≤ 40% as documented by TTE

4. Any of the following cardiac procedures, implants or conditions:

   1. Clinically significant arrhythmias other than AF
   2. Hemodynamically significant valvular disease
   3. Prosthetic heart valve
   4. NYHA Class III or IV CHF
   5. Previous endocardial or epicardial ablation or surgery for AF
   6. Atrial or ventricular septal defect closure
   7. Atrial myxoma
   8. Left atrial appendage device or occlusion
   9. Pacemaker, ICD or CRT
   10. Significant or symptomatic hypotension
   11. Bradycardia or chronotropic incompetence
   12. History of pericarditis
   13. History of rheumatic fever

5. Any of the following within 3 months of enrollment:

   1. Myocardial infarction
   2. Unstable angina
   3. Percutaneous coronary intervention
   4. Heart surgery including coronary artery bypass grafting
   5. Heart failure hospitalization
   6. Stroke or TIA
   7. Clinically significant bleeding
   8. Pericarditis or pericardial effusion
   9. Left atrial thrombus
6. History of blood clotting or bleeding abnormalities.
7. Contraindication to, or unwillingness to use, systemic anticoagulation
8. Contraindications to CT or MRI
9. Sensitivity to contrast media not controlled by premedication
10. Women of childbearing potential who are pregnant, lactating or not using birth control

11. Serious or untreated medical conditions that would prevent participation in the study, interfere with assessment or therapy, or confound data or its interpretation, including but not limited to

    1. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
    2. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
    3. Chronic renal insufficiency of < 60 mL/min/1.73 m2, any history of renal dialysis, or history of renal transplant
    4. Active malignancy or history of treated cancer within 24 months of enrollment
    5. Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
    6. Clinically significant infection
    7. Predicted life expectancy less than one year
12. Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the protocol requirements
13. Current or anticipated enrollment in any other clinical study

Contacts and Locations

Locations

Czechia

Nemocnice Na Homolce

Praha, Czechia

France

CHU Bordeaux

Pessac, France

Sponsors and Collaborators

Farapulse, Inc.

Investigators

• Principal Investigator: Petr Neuzil, MD, PhD; Nemocnice Na Homolce

  Study Documents (Full-Text)

Documents provided by Farapulse, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] February 26, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Farapulse, Inc.
• ClinicalTrials.gov Identifier: NCT03714178
• Other Study ID Numbers: CS0267
• First Posted: October 22, 2018
• Results First Posted: May 4, 2022
• Last Update Posted: May 4, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes