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Recruiting Observational

Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation REFINE-PFA

NCT07275151 · tracked via the Priya Life Science USA tracker
Sponsor
CathVision ApS
Phase
Observational
Started
2026-07-22
Last updated
2026-10-21

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

Pulmonary vein isolation ablation

Pulmonary vein isolation ablation: Electrical isolation of the pulmonary veins to treat atrial fibrillation

Study summary

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

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Eligible subjects will meet all of the following inclusion criteria: 1. Subjects undergoing first time pulmonary vein isolation indicated by investigator for the treatment of atrial fibrillation. 2. Male or non-pregnant female aged ≥21 years. 3. Able and willing to provide written informed consent prior to any clinical investigation related procedure. 4. Subjects in sinus rhythm at the time of the PFA application. Exclusion Criteria: Eligible subjects will not meet any of the following exclusion criteria: 1. Pregnant or nursing subjects. 2. Current participation in another investigational drug or device study that interferes with this study. 3. Subjects who, in the opinion of the investigator, are not candidates for this study. 4. Patients who have had a prior ablation procedure. 5. 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. 6. Life expectancy is less than 12 months, in the opinion of the investigator. 7. Subjects who, in the opinion of the investigator, are considered part of any vulnerable population. 8. Subjects unlikely to be in sinus rhythm at the time of the procedure or unlikely to remain in sinus rhythm after cardioversion

Primary outcome measure(s)

  • Pulmonary vein isolation — intra-procedural
    assess the agreement between pulmonary vein isolation status as determined by the operator using entrance block as well as exit block during PV pacing and as classified by the PFAnalyzer software based on unipolar local potential characteristics analyzed off-line, post procedure.

Trial sites (2)

FacilityCityRegionStatus
Trinity Health Ann Arbor Hospital Ypsilanti Michigan Not Yet Recruiting
The Valley Hospital Paramus New Jersey Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07275151 on ClinicalTrials.gov ↗ ← All trials in the USA