Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorCharles University, Czech Republic
Academic / other
Locations1 site (Prague)
StatusRecruiting
StartedNovember 1, 2025
Main results expectedNovember 1, 2026
Study endsNovember 1, 2026
Registry record updatedMarch 18, 2026
Trial IDNCT07439016 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.