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Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF

RecruitingNAAges 18 Years - 75 YearsAllCardioFocus
NCT06828939 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * overall good health as established by multiple criteria
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What it tests

  • pulsed field ablation
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Where

1 site
Na Homolce Hospital
Prague, Czechia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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