Left atrial and appendage function after pulsed-field pulmonary vein isolation in paroxysmal AF
Official title: Acute Impairment in Left Atrial and Left Atrial Appendage Function Pre- and Post-Pulse Field Ablation Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation: A Prospective Intraprocedural Intracardiac Echocardiography Study
Run by Charles University, Czech Republic · NCT07439016 · Data updated 2026-11-12
We will test whether pulsed-field pulmonary vein isolation causes immediate changes in left atrial and left atrial appendage function in adults with paroxysmal atrial fibrillation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Charles University, Czech Republic Academic / other |
| Locations | 1 site (Prague) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | November 1, 2026 |
| Study ends | November 1, 2026 |
| Registry record updated | March 18, 2026 |
| Trial ID | NCT07439016 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with symptomatic, drug-refractory paroxysmal AF who are in sinus rhythm at procedural onset and are scheduled for a first-time PFA-PVI, without prior atrial ablation, significant valvular disease, or prior LAA closure.
✕Probably not a fit
Patients with persistent or long-standing AF, prior atrial ablation, significant valvular disease, prior LAA closure, or those not in sinus rhythm at procedure onset are excluded and unlikely to benefit from these findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-center observational study enrolling consecutive adults with symptomatic, drug-refractory paroxysmal AF undergoing first-time pulsed-field ablation for pulmonary vein isolation. Intracardiac echocardiography (ICE) will be used during the procedure to measure left atrial and left atrial appendage mechanical function before and immediately after PFA-PVI. The primary outcome is the acute change in LAA mechanical function, while secondary outcomes include changes in trans-mitral diastolic flow patterns, the incidence of new LAA functional stunning (≥20% reduction in LAA EF or a clinically significant drop in LAA emptying velocity), and the correlation with pre-procedural TTE measures of LA strain and LAVI. Results are intended to clarify whether a transient stunning effect exists and to inform peri-procedural anticoagulation management.
Why it matters
Potential benefit: If successful, the results could clarify immediate effects of PFA on LA/LAA function and help tailor peri-procedural anticoagulation to reduce thromboembolic risk.
How similar studies have gone: Pulsed-field ablation has shown promising safety and pulmonary vein isolation efficacy in prior studies, but intraprocedural ICE-based quantification of acute LA/LAA functional changes is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Paroxysmal AF in sinus rhythm at procedural onset Exclusion Criteria: * Persistent or long-standing AF * Prior atrial ablation * Significant valvular disease * A history of LAA closure
Where it's running
-
University Hospital Kralovske Vinohrady
Prague, Czechia Recruiting
Study contacts
- Study coordinator: Marek Hozman, MD, PhD
- Email: marek.hozman@fnkv.cz
- Phone: +420267161111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.