FARA-Free: A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Paroxysmal Atrial Fibrillation
- Sponsor
- Farapulse, Inc.
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE Ablation System Plus with commercial design devices is both safe and effective for treating drug-resistant paroxysmal atrial fibrillation (PAF).
Detailed Description
This is a prospective, multi-center, single arm safety and effectiveness pilot study. Subjects will undergo percutaneous PFA ablation for pulmonary vein isolation and at the clinical discretion of the investigator receive PFA ablation of additional arrhythmogenic locations. Subjects will be followed at 7 days (telephonic), 30 days, 90 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90-day Blanking Period and other relevant outcome measures.
Investigators
Eligibility Criteria
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
- •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.
Exclusion Criteria
- •Subjects will be excluded from participating in this study if they meet any one of the following exclusion criteria:
- •AF that is:
- •Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
- •Longstanding
- •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
- •Previous endocardial or epicardial ablation or surgery for AF
- •Hemodynamically significant valvular disease
- •Prosthetic heart valve
Outcomes
Primary Outcomes
Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter
Time Frame: 12 months
Includes both acute procedural success (successful electrical isolation of set of lesions around the ostia of all pulmonary veins) and therapeutic success (Re-treatment for AF with ablation using study devices, or if necessary, a commercially approved ablation device after a 3 month blanking period constitute a treatment failure.
Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events
Time Frame: 7 days to12 Months
Includes serious adverse events which are device- or procedure-related, and as define din Composite Safety Endpoint definition table occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.