PersAFOne II(Pronounced Per-'Se-fa-nē 2); Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Persistent Atrial Fibrillation
- Sponsor
- Farapulse, Inc.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Acute Procedural Success; Acute Vein Succes
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The objective of this safety and feasibility study is to assess whether the endocardial creation of electrically nonconductive lesions via PEF catheter ablation applied using the FARAPULSE Cardiac Ablation System Plus is a feasible and safe treatment for PersAF and associated AFL
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, 60 ± 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
- •Patients are required to meet all the following inclusion criteria to participate in this study:
- •Age 18-75 Patients with documented drug-resistant symptomatic persistent AF
- •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 prior to the Enrollment Date demonstrating 24 hours of continuous AF
- •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
Acute Procedural Success; Acute Vein Succes
Time Frame: Index Procedure
Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Cardiac Ablation System Plus during the first ablation procedure (Index or Rescheduled Index Procedure)
Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs
Time Frame: 12 Months
Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEsEndpoint(CSE) defined as the incidence of the following late-onset serious adverse events (SAEs) which are device- or procedure-related, as adjudicated by the Clinical Events and Data Monitoring Committee (CEDMC).