Left atrial and appendage function after pulsed-field pulmonary vein isolation in paroxysmal AF
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
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charles University, Czech Republic Academic / other |
| Locations | 1 site (Prague) |
| Trial ID | NCT07439016 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Prague
- University Hospital Kralovske Vinohrady — Prague, Czechia (Recruiting)
Study contacts
- Study coordinator: Marek Hozman, MD, PhD
- Email: marek.hozman@fnkv.cz
- Phone: +420267161111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.