Prognostic Factors for Ablation of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

The Identification of Prognostic Factors for Patients Undergoing Ablation for Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05716581
• Other study ID #: Prognostic AF
• Status: Not yet recruiting
• Start date: March 1, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: February 2023
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 1, 2026
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• atrial fibrillation

Exclusion Criteria:

• absent of informed content

Related Conditions & MeSH terms

• Atrial Fibrillation
• Catheter Ablation
• Heart Rate Variability

Intervention

Device:
• Catheter ablation
Catheter ablation for atrial fibrillation will be done according to the current medical praxis. Pulmonary vein isolation using either radiofrequency or pulsed-field ablation will be done in all patients. In patients with non-paroxysmal AF, additional ablation lesions (posterior wall ablation, roof or mitral isthmus line, ablation of complex fractionated atrial electrograms) could be done based on the operator´s discretion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF reoccurrence during follow-up	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	1 year after the ablation