Prognostic Factors for Ablation of Atrial Fibrillation

Not yet recruiting

• Conditions: Vectorcardiography; Catheter Ablation; Heart Rate Variability; Atrial Fibrillation; Spectral Analysis

• Registration Number: NCT05716581
• Lead Sponsor: Charles University, Czech Republic

Brief Summary

The aim of the study is to find factors associated with sinus rhythm maintenance after catheter ablation for atrial fibrillation.

Detailed Description

Catheter ablation presents the most effective kind of treatment for atrial fibrillation (AF). However, its efficacy is still limited, and AF reoccurs in approx. 30% of patients during the first year after ablation.

Several factors associated with AF recurrences were found, such as dilated left atrium, higher age, or the duration of AF before the ablation. As it was shown, the detailed analysis of the ECG before the ablation could also serve several important factors that could predict AF reoccurrence.

In the study, all participants who will be referred for AF ablation in the study center will be enrolled. Pre-procedural ECG on the day of the ablation (just during the procedure) will be analysed using several methods: 1) spectral analysis (dominant AF frequency will be determined), 2) heart rate variability (for time and frequency domain analysis), 3) vectorcardiography. All ECG recordings will be analyzed using matlab software.

All participants will have regular follow-up checks at 3, 6, and 12 months after ablation including 24-hour Holter recordings. Based on the rhythm presence during the follow-up, participants will be divided in two groups: 1) AF group (patients with AF recurrences) and 2) sinus rhythm (SR) group (patients without AF reoccurrence during follow-up). AF reoccurrence will be determined at a presence of AF or any other atrial tachycardia lasting \> 30 sec. The results of pre-procedural ECG analysis will be compared between both groups. Logistic regression will be done to determine optimal combination of parameters associated with AF freedom.

Study Timeline

• Study First Submitted: 2023-01-29
• Study First Submitted QC: 2023-01-29
• Status Verified: 2023-02
• Study First Posted: 2023-02-08
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-15
• Study Start: 2023-03-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• atrial fibrillation

Exclusion Criteria

• absent of informed content

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AF reoccurrence during follow-up	1 year after the ablation	AF freedom will be defined as freedom from atrial fibrillation or any other regular atrial tachycardia lasting \> 30sec. Rhythm monitoring will be done using regular Holter recordings