Local Potential Measurement In PFA: A Pilot Study

NCT06877156 | Completed

• 1 other identifier: CVPFA-001
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to collect unipolar signal data during a pulsed field ablation study for the treatment of atrial fibrillation and to test the performance of an algorithm designed to measure the local potential of the unipolar signal in real time.

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (1)

• PFAnalyzer output

  The automated peak-to-peak voltage of the local signal potential output from the PFAnalyzer will be compared to manual measurement of both unipolar and bipolar signals.

  From enrollment to hospital discharge typically 1 day

Study Arms (1)

De Novo PFA ablation

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

Paroxysmal and persistent atrial fibrillation patients referred for a cardiac ablation using pulsed field ablation.

You may qualify if:

• Subjects with paroxysmal or persistent atrial fibrillation (AF) undergoing first time PFA procedure 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

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.

Sponsors & Collaborators

• CathVision ApS: lead

Study Sites (1)

KBC Split

Split, 21000, Croatia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 14, 2025
• Study Start: July 28, 2025
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

CR (1)