Tracking heart signals during pulsed field ablation for atrial fibrillation
Observes heart signals during ablation in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation REFINE-PFA
Key facts
- Where
- Paramus and Ypsilanti, United StatesSee the 2 sites
Where in United States
- The Valley HospitalParamus, United StatesTaking people
- Trinity Health Ann Arbor HospitalYpsilanti, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- CathVision ApS
- Trial code
- NCT07275151
- Record updated
- 21 October 2026
- Original description
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.Read full original descriptionShow less
Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation. REFINE-PFA
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.
Inclusion: Eligible subjects will meet all of the following 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.
Exclusion: Current participation in another investigational drug or device study that interferes with 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; Eligible subjects will not meet any of the following exclusion criteria:; Pregnant or nursing subjects; Subjects who, in the opinion of the investigator, are not candidates for this study; 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.