Prognostic Factors for Ablation of Atrial Fibrillation

Sponsor

Charles University, Czech Republic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05716581

Collaborator

(none)

300

Enrollment

36.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Catheter Ablation Spectral Analysis Vectorocardiography Heart Rate Variability	Device: Catheter ablation

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 ablation could also serve several important factors that could predict AF reoccurence.

In our study, all patients who are referred for AF ablation in our center will be enrolled. Pre-procedural ECG 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) vectorocardiography will be performed (P wave and QRS complex analysis). All ECG recording will be analyzed using Mathlab software.

All patients will have regular follow-up checks at 3, 6, and 12 months after ablation including 24-hour Holter recording. Based on the rhythm presence during the follow-up, patients will be divided in AF group (AF recurrences) and SR group (SR maintenance without AF reoccurence). The results of pre-procedural ECG analysis will be compared between both groups. Logistic regression will be done to determine optimal parameters and combinations associated with SR maintenance.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Mar 1, 2026

Outcome Measures

Primary Outcome Measures

SR maintenance [1 year]
The maintenance of SR during the first year after the ablation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

atrial fibrillation

Exclusion Criteria:

absent of informed content

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Charles University, Czech Republic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Charles University, Czech Republic

ClinicalTrials.gov Identifier:

NCT05716581

Other Study ID Numbers:

Prognostic AF

First Posted:

Feb 8, 2023

Last Update Posted:

Feb 8, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Feb 8, 2023