NCT07721948Not yet recruiting
Assessment of Catheter Tissue Contact in PFA
Assessment of Electrode-tissue Contact and Pulmonary Vein Isolation Durability After Pulsed Field Ablation With a Circular "Single Shot" Catheter in Patients With Paroxysmal Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
Pulmonary vein isolation remains the cornerstone of invasive treatment for atrial fibrlllation. Despite recent technological advances in the field of pulsed field ablation (PFA) pulmonary vein isolation durability and arrhythmia free success rates remain approximately at the level of previous years and the radiofrequency ablation era. Isolation durability during PFA procedures might be enhanced by: 1. Intraprocedural monitoring contact of catheter electrode to atrial tissue. 2. Intraprocedural assessment of the transmurality of irreversible electroporation lesion. The aim of our study is to use intracardiac electrogram (iEGM) based analysis for assessment of catheter-tissue contact and PFA lesion durability.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 14 Jul 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 1 Dec 2028
- Lead sponsor
- University Medical Centre Ljubljana
- Diseases
- Atrial fibrillation
- NCT number
- NCT07721948
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Dec 2026 to the primary completion date, 1 Dec 2028
- 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.
Prior treatment
- Previous left atrial ablation.
Other illness
- Acute life-threatening illness.
Age
- Age \>80 years.
Other
- Contraindication to pulsed field ablation in the left atrium (e.g., presence of a left atrial appendage occlusion device).
- Contraindication to undergoing the procedure under general anesthesia.
- Markedly enlarged left atrium (diameter \>50 mm on echocardiography, LAVI \>50 mL/m²).
- Life expectancy \<1 year.
- Presence of left atrial thrombus.
- Secondary atrial fibrillation.
Who the study is looking for
- Patients with electrocardiographically documented paroxysmal atrial fibrillation (AF), defined according to the European Heart Rhythm Association (EHRA) guidelines
Age in the registry: 18 years to 80 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 |
|---|---|---|---|
| University Medical Centre Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.