Measuring Local Potentials in PFA. MULTI PFA (EU)
Starting soon
Conditions studied: Atrial Fibrillation (AF)
In brief
The study is a prospective, multi-center, exploratory, observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the Affera Sphere 9, FaraWave, PulseSelect, Volt or VariPulse PFA systems. The cohort will be adult patients with paroxysmal or persistent atrial fibrillation (AF) who undergo PVI using PFA.
Key facts
- Study ID
- NCT07379697
- Run by
- CathVision ApS
- People needed
- 30
- Starts
- 2026-04-28
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-03-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects undergoing first time pulmonary vein isolation indicated by investigator for the treatment of atrial fibrillation.
- Male or non-pregnant female aged ≥18 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.
You may not qualify if…
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.