Left Atrial Function After Pulsed Field Ablation of Atrial Fibrillation

Introduction: Pulsed field ablation (PFA) has emerged in routine clinical practice as a new promising technology in catheter-based treatment of atrial fibrillation (AF). The ease of PFA technology enables more extensive ablation in shorter time. On one hand, extensive ablation is advocated to decrease the AF recurrence in persistent patients, on the other hand it is an important predictor of developing left atrial stiff syndrome with a reported incidence rate of 3.7 - 8.2 % in persistent patients during the era of radiofrequency ablation.

Goals of the study: The main hypothesis is that the LA function (strain) will tend to decline after extensive PFA. It will be assessed using transthoracic echocardiography (TTE) and magnetic resonance (MRI).

Secondary endpoint analysis will include the evaluation of the distribution of late gadolinium enhancement (LGE) after ablation compared to baseline scans, evaluation of heart failure biomarkers after ablation, and description of the rate of AF recurrence.

Methods: This project is a prospective, nonrandomised, two-centre (University Hospital Kralovske Vinohrady and University Hospital Motol) observational study including 50 non-paroxysmal AF patients with indication for catheter ablation. Before the ablation, all patients will undergo LGE MRI and TTE (after cardioversion if AF present). The ablation procedure will be performed using pulsed field technology and will include pulmonary vein isolation, posterior wall ablation and mitral isthmus ablation. Patients will be followed for 6 months. 3 months after the ablation, LGE MRI will be performed. TTE examinations will be carried out on the day after the ablation, at 3 and at 6 months. Heart failure biomarkers (N-terminal proatrial natriuretic peptide, fibroblast growth factor 23, and galectin 3) levels will be analysed at baseline, and 3 and 6 months after the procedure. ECG Holter monitoring will be performed at 3- and 6-months visits.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: ablation

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

Contacts and Locations

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

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 procedures

Description

Inclusion Criteria:

• Non-paroxysmal AF with an indication for catheter ablation
• Age above 18
• Signed informed consent

Exclusion Criteria:

• Contraindication to MRI
• BMI > 35 kg/m2
• Contraindication to amiodarone
• Left atrial size > 60 mm
• History of any LA ablation
• Significant valvular disease (mitral regurgitation ¾ or greater, moderate or severe aortic stenosis)
• Severe pulmonary hypertension
• Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective cohort; Non-paroxysmal AF patients	Procedure: ablation; Pulsed field ablation, MRI and TEE examinations (LA strain)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in LA function (strain) by MRI (baseline vs. 3m values)	LA strain (baseline vs. 3 months)	Baseline MRI to 3 months after procedure
Changes in LA function (strain) by TTE (baseline vs. 3m values)	LA strain (baseline vs. 3 months)	Procedure to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in LA fibrosis distribution (LGE MRI) (baseline vs. 3 m values)	LGE evaluation (baseline vs. 3 months MRI)	Baseline MRI to 3 months after procedure
Changes in ANP, FGF 23, GAL 3 levels (baseline vs. 3 m values)	laboratory analysis	baseline vs. 3 m values
AF freedom	defined as an absence of AF/atrial tachycardia lasting > 30 s during follow-up including Holter monitoring	Procedure to 6 months visit
Changes in strain function on TTE over time	comparison of strain values obtained at all 4 time points	baseline TTE to 6 months control

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 22, 2024
• First Submitted That Met QC Criteria: June 22, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: atrial fibrillation; left atrial strain; pulsed field ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: PFA - strain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No