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

NCT06559787 | Active Not Recruiting

• 1 other identifier: AFAT-Studie
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

epicardial fal

Outcome Measures

Primary Outcomes (1)

• Influence of epicardial adipose tissue (EAT) volume on 1 year arrhythmia recurrences after catheter ablation

  influence of EAT volume quantified by volumetric CT segmentation on 1 year arrhythmia recurrences after catheter ablation for paraxysmal or persistent atrial fibrillation

  measurement of epicardial fat at baseline; anamnestic and ECG-control of arrhythmia after 3, 6 and 12 months

Secondary Outcomes (3)

• 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 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 low voltage areas quantified by high density electroanatomical mapping

  measurement of epicardial fat and catheter ablation at baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

at least 200 patients planned

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead
• The German Heart Foundation: collaborator

Study Sites (1)

Deutsches Herzzentrum

München, 80634, Germany

Location

Related Publications (1)

• Englert F, Obermeyer T, Bahlke F, Popa M, Krafft H, Martinez AT, Syvari J, Tydecks M, Dischel D, Koops E, Reiter T, Telishevska M, Lengauer S, Bressem K, Hadamitzky M, Hessling G, Deisenhofer I, Erhard N. Epicardial adipose tissue and ablation outcomes in obese patients with paroxysmal atrial fibrillation: A comparison of pulsed field and radiofrequency ablation. Heart Rhythm O2. 2025 Sep 25;6(12):1901-1910. doi: 10.1016/j.hroo.2025.09.020. eCollection 2025 Dec.

  PMID: 41541734 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nico Erhard, Dr. med.

  Deutsches Herzzentrum München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: August 19, 2024
• Study Start: August 18, 2022
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

DE (1)