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

Not Applicable

Completed

Conditions: Paroxysmal Atrial Fibrillation

Interventions: Device: FARAPULSE Endocardial Multi Ablation System

Registration Number: NCT04170608

Lead Sponsor: Farapulse, Inc.

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

Detailed Description: This is a prospective, multi-center, safety and feasibility study. Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation and at the clinical discretion of the investigator receive PEF ablation of additional arrhythmogenic locations. Subjects will be followed at 30 days, 75 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90-day Blanking Period and other relevant outcome measures.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

Inclusion Criteria

Study subjects are required to meet all the following inclusion criteria to participate in this study:

Patients with documented drug-resistant symptomatic PAF meeting all three of the following criteria:
1. 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.
2. Frequent AF, defined as ≥ 2 episodes within 6 months of enrollment.
3. 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:
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

EXCLUSION CRITERIA: Subjects will be excluded from participating in this study if they meet any one of the following exclusion criteria:

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 ≥ 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:
1. Clinically significant arrhythmias other than AF, AFL or AT
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, implantable cardioverter defibrillator or cardiac resynchronization therapy devices
10. Significant or symptomatic hypotension
11. Bradycardia or chronotropic incompetence
12. History of pericarditis
13. History of rheumatic fever
14. History of congenital heart disease with any residual anatomic or conduction abnormality
Any of the following within 3 months of enrollment:
1. Myocardial infarction
2. Unstable angina
3. Percutaneous coronary intervention
4. Heart surgery (e.g. coronary artery bypass grafting, ventriculotomy, atriotomy)
5. Heart failure hospitalization
6. Stroke or TIA
7. Clinically significant bleeding
8. Pericarditis or pericardial effusion
9. Left atrial thrombus
History of blood clotting or bleeding abnormalities
Contraindication to, or unwillingness to use, systemic anticoagulation
Contraindications to CT or MRI
Sensitivity to contrast media not controlled by premedication
Women of childbearing potential who are pregnant, lactating or not using birth control
Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to:
1. Body mass index (BMI) > 40
2. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
3. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
4. Renal insufficiency with an estimated creatinine clearance < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
5. Active malignancy or history of treated cancer within 24 months of enrollment
6. Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
7. Clinically significant infection
8. Predicted life expectancy less than one year
Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the protocol requirements.
Current or anticipated enrollment in any other clinical study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FARAPULSE Endocardial Ablation	FARAPULSE Endocardial Multi Ablation System	Ablation using the FARAPULSE Endocardial Multi Ablation System

Primary Outcome Measures

Name	Time	Method
Feasibility: Acute Key Procedural Success	Index Procedure	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.
Safety: Number of Participants With Prespecified Primary Safety Events Within 30 Days of Index Procedure.	30 Days	Number of patients with death, MI, diaphragmatic paralysis, stroke/TIA, thromboemolism, pericarditis, tamponade/perforation, vascular access complications, hospitalization, heart block, PV stenosis, atrioesophageal fistula.

Secondary Outcome Measures