Atrial FibrillationCASE-AFNCT03091452
CArdioSurgEry Atrial Fibrillation Register
An observational study of Atrial Fibrillation, run by Stiftung Institut fuer Herzinfarktforschung at 3 sites in Germany.
Trial summary
CASE AF aims to describe the reality of medical care of patients in whom atrial fibrillation is treated by cardiac surgical ablation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 2,000 participants
- Where
- 3 sitesGermany
- Study dates
- Jan 2017to Dec 2029
- How long will I take part?
- 12 Months
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in whom atrial fibrillation is treated by cardiac surgical ablation
Who may be able to join
- Atrial fibrilation
- Treated by cardiac surgical ablation
Who cannot join
- Patient denies participation
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
Schüchtermann Kliniken
Bad Rothenfelde, North Rhine-Westphalia, 49214
Jürgen Ackemann, MD
- Not yet recruiting
Asklepios Harburg
Hamburg, Free and Hanseatic City of Hamburg, 21075
Thorsten Hanke, MD
- Recruiting
Klinikum Bogenhausen
München, Bavaria, 81925
Edgar Eszlari, MD
About this study
Official title: CArdioSurgEry Atrial Fibrillation Register - CASE-AF Register
CASE AF aims to describe the reality of medical care of patients in whom atrial fibrillation is treated by cardiac surgical ablation.
Read the detailed description
CASE AF aims to describe the reality of medical care of patients in whom atrial fibrillation is treated by cardiac surgical ablation. In particular, the following questions should be answered:
- Indication: Which are the different indications for cardiac surgical ablation in patients with atrial fibrillation?
- How often and in which patients the different concepts of surgery and ablation procedures are used? At the same time, how often an intervention at the left atrial appendage is carried out?
- Safety: How secure is the cardiac surgical ablation of atrial fibrillation (periprocedural, during hospital stay and during the long-term follow up)?
- Effectiveness: How effectively is the cardiac surgical ablation of atrial fibrillation (procedural success)? How often are AF recurrences in the long-term follow up?
- What is the concommitant medical treatment after surgical ablation?
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of major bleeding events
Documentation of procedural results and clinical short-and long-term results of the documented therapies
Measured: 12 months
Secondary outcomes (2)
Number of major adverse cardiac events
Documentation of procedural results and clinical short-and long-term results of the documented therapies
Measured: 12 months
Complications during hospital stay
Documentation of hospital mortality, nonfatal major complications
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study startJan 2017
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (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
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Stiftung Institut fuer Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thorsten Hanke, MD, Principal investigator, Asklepios Hamburg Harburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091452
- Sponsor's protocol ID
- CASE-AF
- Acronym
- CASE-AF
- Status last verified
- Oct 2025
- First submitted
- 13 Mar 2017
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Niemann B, Doll N, Grubitzsch H, Hanke T, Knaut M, Senges J, Ouarrak T, Vondran M, Boning A. Surgical Ablation of Atrial Fibrillation in High-Risk Patients: Success versus Risk. Thorac Cardiovasc Surg. 2025 Aug;73(5):373-386. doi: 10.1055/a-2334-9039. Epub 2024 May 28.
PubMed 38806162
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CArdioSurgEry Atrial Fibrillation Register - CASE-AF Register
- ClinicalTrials.gov ID
- NCT03091452
- Acronym / sponsor ID
- CASE-AF / CASE-AF
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Stiftung Institut fuer HerzinfarktforschungUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 27 Mar 2017 (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.
CASE AF aims to describe the reality of medical care of patients in whom atrial fibrillation is treated by cardiac surgical ablation.
Detailed description
CASE AF aims to describe the reality of medical care of patients in whom atrial fibrillation is treated by cardiac surgical ablation. In particular, the following questions should be answered:
- Indication: Which are the different indications for cardiac surgical ablation in patients with atrial fibrillation?
- How often and in which patients the different concepts of surgery and ablation procedures are used? At the same time, how often an intervention at the left atrial appendage is carried out?
- Safety: How secure is the cardiac surgical ablation of atrial fibrillation (periprocedural, during hospital stay and during the long-term follow up)?
- Effectiveness: How effectively is the cardiac surgical ablation of atrial fibrillation (procedural success)? How often are AF recurrences in the long-term follow up?
- What is the concommitant medical treatment after surgical ablation?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in whom atrial fibrillation is treated by cardiac surgical ablation
Key inclusion criteria (2 listed)
- Atrial fibrilation
- Treated by cardiac surgical ablation
Key exclusion criteria (1 listed)
- Patient denies participation
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
Number of major bleeding events
Time frame: 12 months
Documentation of procedural results and clinical short-and long-term results of the documented therapies
2 secondary outcomes
Number of major adverse cardiac events
Time frame: 12 months
Complications during hospital stay
Time frame: 12 months
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 24 Dec 2025.
- Derived from this study: PubMed 38806162Niemann B, Doll N, Grubitzsch H, Hanke T, Knaut M, Senges J, Ouarrak T, Vondran M, Boning A. Surgical Ablation of Atrial Fibrillation in High-Risk Patients: Success versus Risk. Thorac Cardiovasc Surg. 2025 Aug;73(5):373-386. doi: 10.1055/a-2334-9039. Epub 2024 May 28.
- Individual participant dataSharing planned: No
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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.
Thorsten Hanke, MD principal investigator
Asklepios Hamburg Harburg
3 sites 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 Stiftung Institut fuer Herzinfarktforschung at 3 sites 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 1 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 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Belgin Özdemir (00496215032888, oezdemir@stiftung-ihf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of major bleeding events (time frame: 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 NCT03091452, 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 24 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.