Measuring Local Potentials in PFA. MULTI PFA (EU)

NCT07379697 | Not Yet Recruiting

• 1 other identifier: CVPFA-004
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (2)

• Identify a clinically meaningful threshold for residual potentials after PFA delivery

  The peak-to-peak voltage in mV of post-PFA signals identified as local potentials by an experienced electrophysiologist will be recorded

  At the time of the procedure

• Identify a clinically meaningful threshold for residual potentials after PFA delivery

  The peak-to-peak voltage of local potentials identified by an experienced electrophysiologist will be measured in mV by the PFAnalyzer software

  At the time of the procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with atrial fibrillation referred for a cardiac ablation

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

Sponsors & Collaborators

• CathVision ApS: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Karl Firth, MSc

CONTACT

0702097102; kpf@cathvision.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: January 30, 2026
• Study Start (Estimated): April 28, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-01