Actively Recruiting
Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF
Led by CardioFocus · Updated on 2025-10-07
75
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recurrent symptomatic paroxysmal atrial fibrillation with at least one documented episode
- Failure or intolerance of at least one antiarrhythmic drug
- Age 18 to 75 years
- Indicated for an ablation procedure according to guidelines or study site practice
- Willing and able to provide informed consent and participate in baseline and follow-up assessments for the study duration
You will not qualify if you...
- Overall good health as established by multiple criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Na Homolce Hospital
Prague, Czech Republic, Czechia
Actively Recruiting
Research Team
V
Vikramaditya Mediratta, MS
CONTACT
L
Lisa Hausmann, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here