NCT06828939Recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 4 Feb 2025
- Start date
- 12 Dec 2024
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- CardioFocus
- Diseases
- Atrial fibrillation
- NCT number
- NCT06828939
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 12 Dec 2024 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- overall good health as established by multiple criteria
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Na Homolce Hospital Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
Related publications
- Visually Guided Pulsed Field Ablation for Durable Pulmonary Vein Isolation Chronic Remapping and Clinical Outcomes in the First-in-Human VISION AF Study.JACC Clin Electrophysiol · 2026 · PMID 42024567
This page is information, not medical advice. Discuss any trial with your doctor.