Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF
Recruiting · NCT06828939 · Interventional (participants receive a specific treatment) · Lead sponsor: CardioFocus
View the official record on ClinicalTrials.gov →Interventions studied
pulsed field ablation
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Na Homolce Hospital - Prague, Czech Republic, Czechia