Clinical trial NCT03714178: A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation
Official title: PEFCAT: A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Farapulse, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-22
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 30 days~12 Months
Secondary outcomes:
measure: Feasibility: Pulmonary Vein Isolation
timeFrame: 1 Day (Acute)
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Nemocnice Na Homolce
city: Pessac
country: France
facility: CHU Bordeaux
Study officials:
affiliation: Nemocnice Na Homolce
name: Petr Neuzil, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.