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Tests a balloon pulsed field ablation device for short-episode atrial fibrillation

Tests a pulsed field balloon device for atrial fibrillation in adults with short episodes.

Plain-language title generated from the registry record
Registry title: Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF

Key facts

Where
Prague, CzechiaSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Source: NCT06828939, who can take part

Where in Czechia

  • Na Homolce HospitalPrague, CzechiaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
CardioFocus
Trial code
NCT06828939
Record updated
3 August 2026
Original description
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.Read full original descriptionShow less

Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant Pulsed Field Ablation Balloon for the Treatment of Atrial Fibrillation

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.

Inclusion: 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: overall good health as established by multiple criteria.

ClinicalTrials.gov NCT06828939