PersAFOne: Feasibility Study of the FARAPULSE™ Endocardial Ablation System in the Treatment of Persistent Atrial Fibrillation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Persistent Atrial Fibrillation
- Sponsor
- Farapulse, Inc.
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Safety at 30 Days
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
PersAFOne:
Feasibility Study of the FARAPULSE™ Endocardial Ablation System in the Treatment of Persistent Atrial Fibrillation
Detailed Description
This is a prospective, multi-center safety and feasibility study in subjects with persistent AF. Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation as well as cavotricuspid isthmus interruption and other left atrial ablations at the investigator's discretion. Subjects will then be followed at 30 days, 75 ± 15 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 persistent AF meeting all three of the following criteria:
- •Patient is refractory or intolerant to at least one Class I/III antiarrhythmic agent.
- •ECG-documented first episode of persistent AF, lasting longer than 7 days but not longer than 365 days
- •Holter within 90 days of the Enrollment Date demonstrating 24 hours of continuous AF
- •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:
- •Paroxysmal (longest AF episode \< 7days)
- •Longstanding (has persisted \> 12 months or that does not respond to cardioversion if \< 12 months)
- •Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
- •Left atrial anteroposterior diameter ≥ 5.5 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
Safety at 30 Days
Time Frame: 30 Days
Occurrence of primary safety events at 30 days post procedure: death, MI, stroke/TIA, thromboembolism, pericarditis/tamponade, vascular access complications, hospitalization, heart block, PV stenosis, atriosesphageal fistula