Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation: REFINE-PFA
Objective
The study is a prospective, exploratory observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the FaraPulse PFA system. The cohort will be patients with paroxysmal or persistent atrial fibrillation (AF) who undergo PVI using this system.
Eligibility
Key Inclusion Criteria:
- Subjects undergoing first time pulmonary vein isolation indicated by investigator for the treatment of atrial fibrillation.
- Male or non-pregnant female aged ≥21 years.
- Able and willing to provide written informed consent prior to any clinical investigation related procedure.
- Subjects in sinus rhythm at the time of the PFA application.
Key Exclusion Criteria:
- Pregnant or nursing subjects.
- Current participation in another investigational drug or device study that interferes with this study.
- Subjects who, in the opinion of the investigator, are not candidates for this study.
- Patients who have had a prior ablation procedure.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Life expectancy is less than 12 months, in the opinion of the investigator.
- Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.
- Subjects unlikely to be in sinus rhythm at the time of the procedure or unlikely to remain in sinus rhythm after cardioversion
NCT ID
NCT07275151
