A Phase 4 interventional study of CE-mark approved LAA closure devices and Acetylsalicylic acid in Atrial Fibrillation, sponsored by Charite University, Berlin, Germany. Completed at 42 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by Charite University, Berlin, Germany · Phase 4, Interventional, and Prevention
Among 17 studies testing aspirin in Atrial Fibrillation — 3 open to participants now, 3 under way, 1 of them phase 3. Aspirin · Atrial Fibrillation.
Among the 17 studies testing aspirin in Atrial Fibrillation, this one is the 7th largest by enrollment, is the only one that started in 2018, is one of 7 in phase 4, and was the 11th registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 912 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →3 of the 17 studies testing aspirin in Atrial Fibrillation are open now, in 3 countries. Each count lists the studies.
Aspirin: first FDA approval 1950 (PERCODAN), first EMA approval 2010. What it is approved for, and how studies give it, is on its page →
Of the 612 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 44 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →17 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2018.
Median enrollment 614 across the 17 interventional studies. Of the 9 that completed or were terminated, 3 (33%) have results posted.
2 of 17 have an industry lead sponsor. The 10 most frequent:
Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.
Charite University, Berlin, Germany has 9 studies filed under Atrial Fibrillation — fewer than ten, so there is no comparison to draw.
1 of the studies testing aspirin in Atrial Fibrillation that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04796714University Hospital, BordeauxAntiPlatelet theraPy stratEgy followiNg Left Atrial appenDAGe closurE | 2027-05-03 |
Among the 17 studies testing aspirin in Atrial Fibrillation, from their registry updates:
The study goal is to determine the clinical benefit of percutaneous catheter-based left atrial appendage (LAA) closure in patients with non-valvular atrial fibrillation (NVAF) at high risk of stroke (CHA2DS2-VASc Score ≥2) as well as high risk of bleeding as compared to best medical care (including a [non-vitamin K] oral anticoagulant [(N)OAC] when eligible).
The individualized therapy with oral anticoagulants is considered to be an essential preventive therapy in patients with atrial fibrillation. The risk of stroke can be reduced by approximately 65%. However, long-term anticoagulation therapy also increases the risk of major bleeding.
A significant proportion of patients at high risk of stroke do not tolerate long-term anticoagulation due to various relative or absolute contraindications. As demonstrated in previous studies with non-vitamin K antagonist anticoagulants (NOAK), 20-25% of patients were unable to tolerate long-term anticoagulation therapy.
For this reason, additional therapeutic approaches for stroke prevention in patients with atrial fibrillation have been developed.
A promising approach is catheter-based closure of the left atrial appendage, because more than 90% of cardiac thrombi in patients with non-valvular atrial fibrillation are detected in the left atrial appendage. Recent registry studies show that the safety of LAA occluder implantation is promising. However, further scientific studies are required, in order to explore more benefits of the underlying method and eligible patients for implantation.
Study objectives:
The study goal is to determine the clinical benefit of percutaneous catheter-based left atrial appendage (LAA) closure in patients with non-valvular atrial fibrillation (NVAF) at high risk of stroke (CHA2DS2-VASc Score ≥2) as well as high risk of bleeding as compared to best medical care (including a [non-vitamin K] oral anticoagulant [(N)OAC] when eligible).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
High risk of bleeding under oral anticoagulation or for (N)OAC therapy, in particular patients with at least one of the following conditions:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Left atrial appendage closure by use of CE-mark approved LAA closure devices followed by post procedure treatment (antiplatelet therapy e.g. acetylsalicylic acid, clopidogrel)
Device: CE-mark approved LAA closure devices · Drug: Acetylsalicylic acid · Drug: Clopidogrel
No left atrial appendage closure. Treatment with best medical care (NOACs (dabigatran, rivaroxaban, apixaban, edoxaban) or VKA (phenprocoumon, warfarin)
Drug: Dabigatran · Drug: Rivaroxaban · Drug: Apixaban · Drug: Edoxaban · Drug: Phenprocoumon · Drug: Warfarin
LAA closure with post procedure treatment
post procedure treatment according to the physicians (recommendation are made in the protocol); oral anticoagulation is not prescribed in this group
Also known as: ASS
post procedure treatment according to the physicians (recommendation are made in the protocol); oral anticoagulation is not prescribed in this group
Patients allocated to the best medical care group receive either NOAC therapy or VKA
Also known as: Pradaxa®
Patients allocated to the best medical care group receive either NOAC therapy or VKA
Also known as: Xarelto®
Patients allocated to the best medical care group receive either NOAC therapy or VKA
Also known as: Eliquis®
Patients allocated to the best medical care group receive either NOAC therapy or VKA
Also known as: LIXIANA®
Patients allocated to the best medical care group receive either NOAC therapy or VKA
Also known as: Marcumar®
Patients allocated to the best medical care group receive either NOAC therapy or VKA
Also known as: Coumadin®
Primary endpoint (net clinical benefit)
Survival time free of the composite of: * Stroke (including ischemic or hemorrhagic stroke) * Systemic embolism * Major bleeding (BARC type 3-5) * Cardiovascular or unexplained death
Time frame: After 3, 6, and 12 months. Twice a year until 24 months and once a year after 24 months.
Primary endpoint events per year
assessed by the number of primary endpoint events during the follow-up period.
Time frame: After 3, 6, and 12 months. Twice a year until 24 months and once a year after 24 months.
Combined endpoint: MACCE
(stroke/systemic embolism/cardiovascular death/myocardial infarction)
Time frame: After 3, 6, and 12 months. Twice a year until 24 months and once a year after 24 months.
Mortality
(including all-cause death, cardiovascular death, non- cardiovascular death, peri-procedural death)
Time frame: After 3, 6, and 12 months. Twice a year until 24 months and once a year after 24 months.
Major bleeding
BARC type 3-5 (according to the BARC (Bleeding Academic Research Consortium) definition for bleeding).
Time frame: After 3, 6, and 12 months. Twice a year until 24 months and once a year after 24 months.
Systemic embolism
assessed by the rate of systemic embolism during the follow-up period.
Time frame: After 3, 6, and 12 months. Twice a year until 24 months and once a year after 24 months.
Ischemic stroke
Stroke will be assessed according to 2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials: A Report of the American College of Cardiology/AmericanHeart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards). J Am Coll Cardiol, 2015.
Time frame: After 3, 6, and 12 months. Twice a year until 24 months and once a year after 24 months.
Hemorrhagic stroke
Stroke will be assessed according to 2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials: A Report of the American College of Cardiology/AmericanHeart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards). J Am Coll Cardiol, 2015.
Time frame: After 3, 6, and 12 months. Twice a year until 24 months and once a year after 24 months.
Transient ischemic attack
Defined as neurological deficit of vascular origin lasting ≤24 hours without corresponding brain lesion. TIA will be assessed according to 2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials: A Report of the American College of Cardiology/AmericanHeart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards). J Am Coll Cardiol, 2015.
Time frame: After 3, 6, and 12 months. Twice a year until 24 months and once a year after 24 months.
Myocardial infarction
Myocardial infarction will be assessed according to the third universal definition of myocardial infarction (Eur Heart J, 2012).
Time frame: After 3, 6, and 12 months. Twice a year until 24 months and once a year after 24 months.
Hospitalization for bleeding or cardiovascular event
Hospitalization for bleeding or cardiovascular event will be assessed according to 2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials: A Report of the American College of Cardiology/AmericanHeart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards). J Am Coll Cardiol, 2015.
Time frame: After 3, 6, and 12 months. Twice a year until 24 months and once a year after 24 months.
Changes in cognitive function
assessed by MoCA (= Montreal Cognitive Assessment). The MoCA will be used to assess the cognition of patients. Minimum score: 0 points, maximum score: 30 points.
Time frame: At day 0 and after 24 months.
Changes in health-related quality of life
assessed by EQ-5D-5L (German Version 1.0). The EQ-5D-5L consists of a 5-question multi-attribute questionnaire and a visual analogue self-rating scale. Minimum score: 0, maximum score: 100.
Time frame: At day 0 and after 6, and 12 months, twice a year until 24 months and once a year after 24 months of follow-up.
Changes in modified Ranking Scale (mRS)
Time frame: At day 0, 1 day after implantation (device group only) and after 3, 12 and 24 months.
Device-related complications
Device thrombus/fracture/erosion/infection/embolization, Pericardial effusion.
Time frame: Until day 7 or discharge and after 3, 6,12 and 24 months.
Procedure related death
Time frame: Until day 7 or discharge and after 3, 6,12 and 24 months.
Technical and procedural success of device implantation
Time frame: Until day 7 or discharge and after 3, 6,12 and 24 months.
Peri-procedural outcomes
Time frame: At 7 days or discharge, 30 calendar days after implantation and after 3, 6,12 and 24 months.
Additionally, the total number of SAEs will be analyzed.
Time frame: After 3, 6, and 12 months. Twice a year until 24 months and once a year after 24 months.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Aspirin · Clopidogrel
Charite University, Berlin, Germany →