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

August 14, 2024 updated by: Deutsches Herzzentrum Muenchen
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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • München, Germany, 80634
        • Deutsches Herzzentrum

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

at least 200 patients planned

Description

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 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
Influence of epicardial adipose tissue (EAT) volume on 1 year arrhythmia recurrences after catheter ablation
Time Frame: 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
measurement of epicardial fat at baseline; anamnestic and ECG-control of arrhythmia after 3, 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
associations between EAT and gender, BMI, cholesterol levels, body fat
Time Frame: 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
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
Time Frame: 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
Time Frame: measurement of epicardial fat and catheter ablation at baseline
associations between EAT and low voltage areas quantified by high density electroanatomical mapping
measurement of epicardial fat and catheter ablation at baseline

Collaborators and Investigators

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

Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

The German Heart Foundation

Investigators

  • Principal Investigator: Nico Erhard, Dr. med., Deutsches Herzzentrum München

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 (Actual)

August 18, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 14, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFAT-Studie

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.

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