NCT07772518Recruiting
Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation
Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation - the PFA-VISION Randomized Trial (Pulsed Field Ablation - Visualization and Imaging Strategies for Isolation Outcomes in Paroxysmal Atrial fibrillatioN)
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
This is a prospective, randomized clinical trial, which will be conducted in selected European centers. The objective is to compare two commonly used strategies to guide pulsed-field ablation (PFA) in patients with paroxysmal atrial fibrillation (AF). Patients with paroxysmal AF planned to undergo PFA will be randomized to intracardiac echocardiography (ICE)-guided or electroanatomical mapping-guided (OPAL HDx mapping system) ablation procedure. The primary efficacy endpoint will be freedom from atrial arrhythmia (AF, atrial flutter, atrial tachycardia) recurrence off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, with a follow-up duration of 12 months. The primary safety endpoint will be the incidence of predefined safety outcomes.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 292 (estimated)
- First submitted
- 10 Aug 2026
- Start date
- 1 Aug 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Mitera Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07772518
What you commit to
- Study type: Interventional
- Planned participants: 292
- From 1 Aug 2026 to the primary completion date, Dec 2028
- 8 sites in 8 countries
- 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.
Prior treatment
- History of previous left atrial ablation.
Other illness
- NYHA class III/IV heart failure
- Intracardiac thrombus or other conditions making left atrial instrumentation unsafe
- Severe valvular disease
Lab values
- eGFR \< 30 mL/min/1.73 m2
Other
- Any contraindication to AF catheter ablation.
- Need for additional ablation beyond pulmonary vein isolation.
- Inability to provide written informed consent.
- Any factor that, in the investigator's judgment, renders the patient unsuitable for participation or may compromise their safety.
- Major cardiovascular events within 90 days
- Secondary AF owing to reversible causes
Who the study is looking for
- History of paroxysmal AF.
- Scheduled to undergo AF catheter ablation with the FARAPULSE (Boston Scientific) PFA system.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Cardiology, IKEM Coordinator of this site? Confirm its status | Prague | Czechia | Not yet recruiting |
| Hygeia Hospital, 8th Cardiology Department Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| University Hospital Centre Zagreb (KBC Zagreb) Coordinator of this site? Confirm its status | Zagreb | Croatia | Not yet recruiting |
| Heart and Vascular Center, Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Not yet recruiting |
| Marche Polytechnic University / Marche University Hospital Coordinator of this site? Confirm its status | Ancona | Italy | Not yet recruiting |
| Grochowski Hospital, Centre of Postgraduate Medical Education Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| University Medical Centre Ljubljana (UKC Ljubljana) Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Not yet recruiting |
| Department of Arrhythmology, Institute of Cardiovascular Diseases Coordinator of this site? Confirm its status | Banská Bystrica | Slovakia | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.