Prognostic Factors for Ablation of Atrial Fibrillation

February 14, 2023 updated by: Charles University, Czech Republic

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients indicated for the catheter ablation for atrial fibrillation in our center will be enrolled.

Description

Inclusion Criteria:

  • atrial fibrillation

Exclusion Criteria:

  • absent of informed content

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AF reoccurrence during follow-up
Time Frame: 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
1 year after the ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

March 1, 2026

Study Registration Dates

First Submitted

January 29, 2023

First Submitted That Met QC Criteria

January 29, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prognostic AF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AFter study completion, data will be available on the request.

IPD Sharing Time Frame

After study completion

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Clinical Trials on Catheter ablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe