NCT07275151 Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation REFINE-PFA
| NCT ID | NCT07275151 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CathVision ApS |
| Condition | Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-07-22 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2026-07-22 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07275151 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07275151 currently recruiting?
Yes, NCT07275151 is actively recruiting participants. Contact the research team at kpf@cathvision.com for enrollment information.
Where is the NCT07275151 trial being conducted?
This trial is being conducted at Ypsilanti, United States, Paramus, United States.
Who is sponsoring the NCT07275151 clinical trial?
NCT07275151 is sponsored by CathVision ApS. The trial plans to enroll 40 participants.
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