Local Potential Measurement In PFA: A Pilot Study

CathVision

Status: Completed

Conditions: Atrial Fibrillation (AF)

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06877156

CVPFA-001

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

9 participants in 1 patient group

De Novo PFA ablation