Local Potential Measurement In PFA: A Pilot Study

Not yet recruiting

• Conditions: Atrial Fibrillation (AF)

• Registration Number: NCT06877156
• Lead Sponsor: CathVision ApS

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-10
• Study First Posted: 2025-03-14
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Study Start: 2025-06-15
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PFAnalyzer output	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.