Status:
COMPLETED
Local Potential Measurement In PFA: A Pilot Study
Lead Sponsor:
CathVision ApS
Conditions:
Atrial Fibrillation (AF)
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 28 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 30 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06877156
Start Date
July 28 2025
End Date
July 30 2025
Last Update
December 5 2025
Active Locations (1)
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1
KBC Split
Split, Croatia, 21000