Volumetric Quantification of Epicardial Fat Using Semiautomated High Resolution Atrial CT Segmentation in Patients With Atrial Fibrillation Receiving Catheter Ablation

Active, not recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT06559787
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief Summary

The goal of this prospective observational study is to learn about the influence of epicardial fat on the success of catheter ablation in patients with atrial fibrillation.

Detailed Description

A volumetric quantification of epicardial fat is examined by dual source cardiac computet tomography in patients with paroxysmal or persistent atrial fibrillation prior to receiving their first catheter ablation for atrial fibrillation. After ablation the recurrence of arrhythmia is examined after 3 and 6 months respectively.

Study Timeline

• Study Start: 2022-08-18
• Study First Submitted: 2024-07-09
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-14
• Last Update Submitted: 2024-08-14
• Study First Posted: 2024-08-19
• Last Update Posted: 2024-08-19
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• patients with planned catheter ablation due to paroxysmal or persistent atrial fibrillation
• written informed consent
• planned computet tomography

Exclusion Criteria

• history of left atrial catheter ablation
• minor patients or patients not capable of giving written informed consent
• contraindication for computet tomography with contrast agents (e.g. allergy to contrast agents or relevant renal insufficiency or hyperthyreosis)
• patients with congenital heart defects or history of cardial surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Influence of epicardial adipose tissue (EAT) volume on 1 year arrhythmia recurrences after catheter ablation	measurement of epicardial fat at baseline; anamnestic and ECG-control of arrhythmia after 3, 6 and 12 months	influence of EAT volume quantified by volumetric CT segmentation on 1 year arrhythmia recurrences after catheter ablation for paraxysmal or persistent atrial fibrillation

Secondary Outcome Measures

Name	Time	Method
associations between EAT and gender, BMI, cholesterol levels, body fat	measurement of epicardial fat at baseline; anamnestic and ECG-control of arrhythmia after 3, 6 and 12 months	associations between EAT and gender, BMI, cholesterol levels, body fat
associations between EAT and low voltage areas quantified by high density electroanatomical mapping	measurement of epicardial fat and catheter ablation at baseline	associations between EAT and low voltage areas quantified by high density electroanatomical mapping
associations between EAT and left atrial wall thining	measurement of epicardial fat at baseline; anamnestic and ECG-control of arrhythmia after 3, 6 and 12 months	associations between EAT and left atrial wall thining

Trial Locations

Locations (1)

Deutsches Herzzentrum; 🇩🇪 München, Germany