The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Arrhythmia
- Sponsor
- Acutus Medical
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Proportion of subjects who are free from device/procedure related Major Adverse Events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)
Detailed Description
This clinical study is designed to evaluate the safety and performance of the PFA System in the ablation treatment of atrial fibrillation (AF). Data will be used to support regulatory submissions.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female between the ages of 18 to 80 years at time of consent
- •Clinically indicated and scheduled for a de novo catheter ablation of AF
- •Willing and able to provide written informed consent to participate in the study and agree to comply with all follow-up visits and evaluations for the duration of the study.
Exclusion Criteria
- •In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications, atrial thrombus, renal failure, or sepsis.
- •Continuous episodes of AF duration lasting longer than 12-months
- •Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
- •Previous history of left atrial ablation (including surgical treatment) for AF/AT/AFL.
- •Structural heart disease or cardiac history as described below:
- •Left ventricular ejection fraction (LVEF) \< 35%
- •Left atrial size \> 60 mm
- •Evidence of heart failure (NYHA Class III or IV)
- •Unstable angina or ongoing myocardial ischemia
- •Recent myocardial infarction
Outcomes
Primary Outcomes
Proportion of subjects who are free from device/procedure related Major Adverse Events
Time Frame: 6 months
The Primary Endpoint for Safety is an analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the ablation procedure through 6-months.
Acute documentation of pulmonary vein isolation (PVI) for each treated pulmonary vein (PV)
Time Frame: 20 minutes post ablation
The Primary Endpoint for efficacy is the number of subjects where ablation of each accessible pulmonary vein (PV) resulted in confirmation of electrical isolation of the pulmonary vein (PVI) 20 minutes following the last index PFA/RF application with the investigational device
Secondary Outcomes
- Analysis of all identified SAEs, SADEs, and UADEs(12 months)
- Subjects with freedom from an atrial arrhythmia(12 months)