Atrial FibrillationPAfOSASNCT07857044
Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities
An observational study of Atrial Fibrillation and Sleep Apnea, run by Christina Berr. MD at 1 site in Germany.
Trial summary
Pulmonary vein isolation is an established intervention for atrial fibrillation. Patients with a paroxysmal atrial fibrillation have no or only few comorbidities and a good prognosis in respect to their atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Sleep Apnea, Primary Aldosteronism
- What is being tested?
- Screening on comorbidites
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 31 Mar 2023to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with persistent atrial fibrillation, eligible for ablation
Who may be able to join
- persistent atrial fibrillation, eligible for ablation
- BMI 19-40
Who cannot join
- valvular atrial fibrillation
- formerly ablation
- medication interfereing with measurements of atrial fibrosis
- known or treated comorbidities (OSAS, PA)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University hospital Augsburg
Augsburg, Bavaria, 86156
Christina M Berr, MD, +49821/400-165998 ext. -2355, Christina.Berr@uk-augsburg.de
David Reek, MD, +49821/400-161182, David.Reek@uk-augsburg.de
About this study
Official title: Left-atrial Fibrosis in Persistent Atrial Fibrillation, Sleep Apnoe and Primary Aldosteronism
Pulmonary vein isolation is an established intervention for atrial fibrillation. Patients with a paroxysmal atrial fibrillation have no or only few comorbidities and a good prognosis in respect to their atrial fibrillation. In contrast, patients with persistent atrial fibrillation often suffer from relevant comorbidities and recurrence of atrial fibrillation is common. Left-atrial fibrosis and its electrophysiological consequences are involved in the recurrence rate, but pathophysiological mechanisms are yet to be better characterized. The study investigates relevant comorbidities to elucidated their effect on atrial fibrosis and recurrence rates of atrial fibrillation. Furthermore, the investigators evaluate the prevalence of these comorbidities.
Read the detailed description
Pulmonary vein isolation is an established intervention for atrial fibrillation. Patients with a paroxysmal atrial fibrillation have no or only few comorbidities and a good prognosis in respect to their atrial fibrillation. In contrast, patients with persistent atrial fibrillation often suffer from relevant comorbidities and recurrence of atrial fibrillation is common. Left-atrial fibrosis and its electrophysiological consequences are involved in the recurrence rate, but pathophysiological mechanisms are yet to be better characterized. The study investigates relevant comorbidities to elucidated their effect on atrial fibrosis and recurrence rates of atrial fibrillation. Furthermore, the investigators evaluate the prevalence of these comorbidities.
- Conditions
- Atrial Fibrillation, Sleep Apnea, Primary Aldosteronism
- Being tested
- Screening on comorbidites
- Medical subject headings
- Atrial Fibrillation, Sleep Apnea Syndromes, Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening on comorbiditesDiagnostic test
Patients with persistent atrial fibrillation that undergo ablation are screened for comorbidities
What is being measured
The primary outcome is the main question the study is designed to answer.
quantification of area of left-atrial fibrosis in the heart
During ablation elecrical maping of the left-atrium is done and percentage of left-atrial fibrosis (electrical tissue abnormalities) will be assessed
Measured: baseline
Rate of recurrence of atrial fibrillation (yes/no) in the study group
measure the recurrence of AF in follow-up with holter-ekgs
Measured: 1 year after procedure (ablation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start31 Mar 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christina Berr. MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christina Berr. MD, University Hospital Augsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857044
- Sponsor's protocol ID
- IMD-PAfOSAS
- Acronym
- PAfOSAS
- Status last verified
- Sep 2026
- First submitted
- 29 Mar 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be available on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left-atrial Fibrosis in Persistent Atrial Fibrillation, Sleep Apnoe and Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT07857044
- Acronym / sponsor ID
- PAfOSAS / IMD-PAfOSAS
- Conditions
- Atrial Fibrillation, Sleep Apnea, Primary Aldosteronism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Christina Berr. MDUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 5 Oct 2026 (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.
Pulmonary vein isolation is an established intervention for atrial fibrillation. Patients with a paroxysmal atrial fibrillation have no or only few comorbidities and a good prognosis in respect to their atrial fibrillation. In contrast, patients with persistent atrial fibrillation often suffer from relevant comorbidities and recurrence of atrial fibrillation is common. Left-atrial fibrosis and its electrophysiological consequences are involved in the recurrence rate, but pathophysiological mechanisms are yet to be better characterized. The study investigates relevant comorbidities to elucidated their effect on atrial fibrosis and recurrence rates of atrial fibrillation. Furthermore, the investigators evaluate the prevalence of these comorbidities.
Detailed description
Pulmonary vein isolation is an established intervention for atrial fibrillation. Patients with a paroxysmal atrial fibrillation have no or only few comorbidities and a good prognosis in respect to their atrial fibrillation. In contrast, patients with persistent atrial fibrillation often suffer from relevant comorbidities and recurrence of atrial fibrillation is common. Left-atrial fibrosis and its electrophysiological consequences are involved in the recurrence rate, but pathophysiological mechanisms are yet to be better characterized. The study investigates relevant comorbidities to elucidated their effect on atrial fibrosis and recurrence rates of atrial fibrillation. Furthermore, the investigators evaluate the prevalence of these comorbidities.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with persistent atrial fibrillation, eligible for ablation
Key inclusion criteria (2 listed)
- persistent atrial fibrillation, eligible for ablation
- BMI 19-40
Key exclusion criteria (4 listed)
- valvular atrial fibrillation
- formerly ablation
- medication interfereing with measurements of atrial fibrosis
- known or treated comorbidities (OSAS, PA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening on comorbiditesPatients with persistent atrial fibrillation that undergo ablation are screened for comorbidities | Diagnostic test | – |
Primary outcome
quantification of area of left-atrial fibrosis in the heart
Time frame: baseline
During ablation elecrical maping of the left-atrium is done and percentage of left-atrial fibrosis (electrical tissue abnormalities) will be assessed
Rate of recurrence of atrial fibrillation (yes/no) in the study group
Time frame: 1 year after procedure (ablation)
measure the recurrence of AF in follow-up with holter-ekgs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Undecided. Data will be available on reasonable request.
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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.
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 and Sleep Apnea, run by Christina Berr. MD 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 2 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina M Berr, MD (+49821/400-165998 ext. -2355, Christina.Berr@uk-augsburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quantification of area of left-atrial fibrosis in the heart (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2026.