Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF
Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant Pulsed Field Ablation Balloon for the Treatment of Atrial Fibrillation
CardioFocus
75 participants
Dec 12, 2024
INTERVENTIONAL
Conditions
Summary
This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal (short-duration) AF who have not had a previous catheter ablation for AF will be considered for the study. Patients will be followed for one year after the initial ablation procedure.
Eligibility
Inclusion Criteria5
- Recurrent symptomatic PAF with at least one documented episode
- Failure or intolerance of at least one AAD
- Age 18-75 years
- Patient is indicated for an ablation procedure according to society guidelines or study site practice
- Patient is willing and able to give informed consent/participate in baseline and follow-up assessments for the duration of the study
Exclusion Criteria1
- overall good health as established by multiple criteria
Interventions
Pulsed field ablation using a ultra-compliant endoscopic PFA balloon.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06828939