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Completed

NCT Number: NCT06877156

Local Potential Measurement In PFA: A Pilot Study

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

KBC Split

Split, 21000, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. PFAnalyzer output

    Time frame: From enrollment to hospital discharge typically 1 day

    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.

Sponsors and collaborators

Lead sponsor

CathVision ApS

Industry

Registry information

Official study title

Unipolar Signal Local Potential Measurement in Pulsed Field Ablation: A Pilot Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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