Local Potential Measurement In PFA: A Pilot Study

NCT ID: NCT06877156

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-28

Study Completion Date

2025-07-30

Brief Summary

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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

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Conditions

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Atrial Fibrillation (AF)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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De Novo PFA ablation

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CathVision ApS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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KBC Split

Split, , Croatia

Site Status

Countries

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Croatia

Other Identifiers

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CVPFA-001

Identifier Type: -

Identifier Source: org_study_id

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