PEFCAT II: Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Paroxysmal Atrial Fibrillation
- Sponsor
- Farapulse, Inc.
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Feasibility: Acute Key Procedural Success
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
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 meeting all three of the following criteria:
- •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.
- •Frequent AF, defined as ≥ 2 episodes within 6 months of enrollment.
- •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:
- •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
- •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:
- •Persistent (by diagnosis or duration \> 7 days)
- •Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
- •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:
- •Clinically significant arrhythmias other than AF, AFL or AT
- •Hemodynamically significant valvular disease
- •Prosthetic heart valve
Outcomes
Primary Outcomes
Feasibility: Acute Key Procedural Success
Time Frame: 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.
Time Frame: 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.