LA Function After PFA 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

A prospective study that investigates the changes in LA echocardiographic parameters after PFA for paroxysmal AF.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Diagnostic test: LA and LAA function measurements

Detailed Description

This study will leverage ICE to define the acute effects of PFA-PVI on LA and LAA function. The findings will deliver pivotal insights into the functional safety of PFA, clarifying whether a transient stunning effect exists and informing the evolution of peri-procedural anticoagulation management.

Research Objectives

Primary Objective:

To quantify the acute changes in LAA mechanical function immediately following PVI using PFA in patients with paroxysmal AF, as assessed by intraprocedural ICE.

Secondary Objectives:

1. To characterize the acute changes in trans-mitral diastolic flow patterns (E velocity, A velocity, E/A ratio, E deceleration time) as surrogate markers of left atrial pressure and compliance following PFA-PVI.
2. To determine the incidence of new-onset LAA functional stunning, defined as a≥20% reduction in LAA ejection fraction (LAA EF) and/or a clinically significant drop in LAA emptying velocity (LAA Ev) compared with baseline.
3. To explore the correlation between pre-procedural LA strain/LAVI measured by TTE and the degree of acute LAA functional impairment post-PFA.

Research Methods

Study Design A prospective, single-center observational study enrolling consecutive patients with symptomatic, drug-refractory paroxysmal AF undergoing first-time PFA-PVI.

Study Population Inclusion criteria: Adults (≥18 years) with 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 Procedural Protocol All PFA procedures will be performed under deep sedation or general anaesthesia using the FARAPULSETM system (Boston Sci.) according to the current recommendations. To measure the LAA and transmitral velocities, an ICE probe will be positioned transeptally into the LA at the beginning and end of the procedure. For this purpose, the transseptal puncture dedicated to the ablation catheter will be utilized; therefore, the study protocol does not require an additional transseptal puncture

PreProcedural TTE:

Comprehensive TTE within 24 hours before ablation will include LVEF, LA volumes, transmitral inflow velocities (E, A), tissue Doppler velocities (e', a'), and advanced strain analysis (reservoir, conduit, contractile strain).

Intra-Procedural ICE:

1. Mitral Inflow Indices: E velocity, A velocity, E/A ratio, and E deceleration time.
2. LAA Functional Indices: LAA emptying velocity (Ev), filling velocity (Fv), maximal area (Amax), minimal area (Amin), and ejection fraction calculated by the area method:

LAA EF = (LAA Amax - LAA Amin) / LAA Amax × 100%. All measurements will be obtained across three cardiac cycles before and within five minutes after completion of PFA PVI.

Endpoints

1. Primary endpoint: Change in LAA EF and LAA Ev between pre- and post- PFA measurements.

2. Secondary endpoints:

   • Variation in diastolic indices;
   • Proportion of patients demonstrating new-onset LAA stunning
   • correlations with pre-ablation strain/LAVI parameters.

Data Analysis Continuous variables will be summarized as mean ± SD or median (IQR) based on distribution. Pre/post comparisons will use paired t-tests or Wilcoxon signed-rank tests; binary outcomes will employ McNemar's test. Linear regression models will explore relationships between baseline atrial metrics and magnitude of acute functional decline.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Marek Hozman, MD, PhD; Phone Number: +420267161111; Email: marek.hozman@fnkv.cz

Study Locations

• Czechia
  • Prague, Czechia
    • Recruiting
    • University Hospital Královské Vinohrady

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for AF ablation.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Measurement of the LA and LAA echocardiographic parameters pre- and post-PFA for paroxysmal AF.	Diagnostic test: LA and LAA function measurements; ICE measurements of the LA and LAA function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1. Change in LAA Ev between pre- and post- PFA measurements.	During the procedure

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: atrial fibrillation; catheter ablation; LA function
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: LA function PFA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No