Atrial FibrillationAFATNCT06559787
Volumetric Quantification of Epicardial Fat Using Semiautomated High Resolution Atrial CT Segmentation in Patients With Atrial Fibrillation Receiving Catheter Ablation
An observational study of Atrial Fibrillation, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 18 Aug 2022to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: at least 200 patients planned
Who may be able to join
- patients with planned catheter ablation due to paroxysmal or persistent atrial fibrillation
- written informed consent
- planned computet tomography
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Keywords
- epicardial fal
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
associations between EAT and gender, BMI, cholesterol levels, body fat
Measured: 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
associations between EAT and left atrial wall thining
Measured: 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
associations between EAT and low voltage areas quantified by high density electroanatomical mapping
Measured: measurement of epicardial fat and catheter ablation at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start18 Aug 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- The German Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Nico Erhard, Dr. med., Principal investigator, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559787
- Sponsor's protocol ID
- AFAT-Studie
- Acronym
- AFAT
- Status last verified
- Aug 2024
- First submitted
- 9 Jul 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41541734
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Quantification of Epicardial Fat Using Semiautomated High Resolution Atrial CT Segmentation in Patients With Atrial Fibrillation Receiving Catheter Ablation
- ClinicalTrials.gov ID
- NCT06559787
- Acronym / sponsor ID
- AFAT / AFAT-Studie
- Conditions
- Atrial Fibrillation
- Keywords
- epicardial fal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Collaborators
- The German Heart Foundation
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- at least 200 patients planned
Key inclusion criteria (3 listed)
- patients with planned catheter ablation due to paroxysmal or persistent atrial fibrillation
- written informed consent
- planned computet tomography
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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 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 low voltage areas quantified by high density electroanatomical mapping
Time frame: measurement of epicardial fat and catheter ablation at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Derived from this study: PubMed 41541734Englert 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.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nico Erhard, Dr. med. principal investigator
Deutsches Herzzentrum München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06559787, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.