Viewing Study NCT06478342



Ignite Creation Date: 2024-07-17 @ 11:11 AM
Last Modification Date: 2024-10-26 @ 3:33 PM
Study NCT ID: NCT06478342
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-06-27
First Post: 2024-06-22

Brief Title: Left Atrial Function After Pulsed Field Ablation of Atrial Fibrillation
Sponsor: Charles University Czech Republic
Organization: Charles University Czech Republic

Study Overview

Official Title: Left Atrial Function After Pulsed Field Ablation of Atrial Fibrillation
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 37 - 82 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None