Back to resultsLeft Atrial Appendage CLOSURE in Patients With Atrial Fibrillation Compared to Medical Therapy (CLOSURE-AF)
Primary Purpose
Atrial Fibrillation
Status
Recruiting
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
CE-mark approved LAA closure devices
Acetylsalicylic acid
Clopidogrel
Dabigatran
Rivaroxaban
Apixaban
Edoxaban
Phenprocoumon
Warfarin
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Anticoagulation, Left atrial appendage closure, Stroke
Eligibility Criteria
Key Inclusion Criteria:
- Signed written informed consent
- Documented atrial fibrillation (paroxysmal, persistent, long-standing persistent or permanent)
- CHA2DS2VASc-Score ≥ 2
High risk of bleeding under oral anticoagulation or contraindication for (N)OAC therapy, in particular patients with at least one of the following conditions (a-e):
- HAS-BLED-Score ≥ 3
- Prior intracranial/intraspinal bleed, intraocular bleed compromising vision (BARC: type 3c)
- Hemorrhagic/bleeding complication fulfilling BARC type 3a or 3b: gastrointestinal tract, genitourinary tract or respiratory tract bleeding, where the patient is considered to be at a persistently increased risk of bleeding, e.g. the cause of bleeding cannot be successfully eliminated
- Chronic kidney disease with eGFR 15-29 ml/min/1.73 m2
- Any recurrent bleeding making chronic anticoagulation not feasible
- Subject eligible for an LAA occluder device
- Age ≥18 years
- Willing and capable of providing informed consent, participating in all associated study activities
Key Exclusion Criteria:
- Absolute contraindication to acetylsalicylic acid
- Comorbidities other than AF requiring chronic (N)OAC therapy, e.g. mechanical heart valve prosthesis
- Symptomatic carotid disease (if not treated)
- Complex aortic atheroma with mobile plaque (Kronzon classification grade V)
- Heart transplant
- Active infection or active endocarditis or other infections resulting in bacteremia
- Cardiac tumor
- Severe liver failure (Child-Pugh class C or liver failure with coagulopathy)
- Severe renal failure (GFR <15 ml/min/1.73m2)
- Pregnancy or breastfeeding
- For female patients of reproductive potential: Unwilling to agree to use a highly effective method of contraception (Pearl index <1) throughout the study period
- Subject with participation in another interventional clinical trial during this study or within 30 days before entry into this trial.
- Known terminating disease with life expectancy <1 year (including those with end-stage heart failure)
- Subjects, who are committed to an institution due to binding official or court order
- Subject who is dependent on the Site, the Site Investigator, any sub- investigator, his/her representative and/or the sponsor
- Persons who are not proficient in the German language
- Acute heart failure within the last 30 days
- Cardiac intervention within the last 30 days
- Subjects with planned cardiac or non-cardiac surgery or intervention. (These subject can be included 30 days after such intervention / surgery.)
Sites / Locations
- Vivantes Klinik Am Urban, KardiologieRecruiting
- Charité Universitätsmedizin Berlin, CBF, KardiologieRecruiting
- Vivantes Klinikum Neukölln, KardiologieRecruiting
- DRK-Kliniken Berlin Köpenick, Klinik für Innere Medizin - Schwerpunkt Kardiologie und AngiologieRecruiting
- Charité Universitätsmedizin Berlin, CVK, KardiologieRecruiting
- Deutsches Herzzentrum Berlin, Innere Medizin - KardiologieRecruiting
- Klinikum Brandenburg GmbH, Zentrum für Innere Medizin IRecruiting
- Gesundheit Nord gGmbH, Klinikum Links der Weser, Klinik für Kardiologie und AngiologieRecruiting
- Klinikum Lippe, Klinik für Kardiologie, Angiologie und Internistische IntensivmedizinRecruiting
- Katholisches Krankenhaus "St. Johann Nepomuk", Klinik für Innere Medizin II - KardiologieRecruiting
- Universitätsklinikum Erlangen, Medizinische Klinik II - Kardiologie und AngiologieRecruiting
- Alfried Krupp KrankenhausRecruiting
- Universität Greifswald, Klinik für Innere Medizin B - KardiologieRecruiting
- Asklepios Klinik Barmbek, I. Med. Abteilung - KardiologieRecruiting
- Klinikum Herford, Med. Klinik III/ KardiologieRecruiting
- Westpfalz-Klinikum GmbH, Klinik für Innere Medizin II - KardiologieRecruiting
- UKSH - Campus Kiel, Medizinische Klinik III - Kardiologie, Angiologie, IntensivmedizinRecruiting
- UKSH - Universitäres Herzzentrum Lübeck, Medizinische Klinik II - Kardiologie, Angiologie, IntensivmedizinRecruiting
- Universitätsmedizin Mainz, Kardiologie I - Zentrum für KardiologieRecruiting
- Universitätsmedizin Mannheim, I. Medizinische Klinik - Kardiologie, Angiologie, IntensivmedizinRecruiting
- Deutsches Herzzentrum München, Klinik an der TU MünchenRecruiting
- LMU Universität München, Medizinische Klinik und Poliklinik IRecruiting
- Peter Osypka Herzzentrum MünchenRecruiting
- Städt. Klinikum München GmbH, Klinikum Neuperlach, Klinik für Kardiologie, Pneumologie, intern. IntensivmedizinRecruiting
- Universitätsklinik Ulm, Klinik für Innere Medizin II - KardiologieRecruiting
- Heinrich-Braun-Klinikum Zwickau, Klinik für Innere Medizin I - Kardiologie, Angiologie, Intern. InternsivmedizinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LAA closure group
Best medical care group
Arm Description
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)
No left atrial appendage closure. Treatment with best medical care (NOACs (dabigatran, rivaroxaban, apixaban, edoxaban) or VKA (phenprocoumon, warfarin)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Primary endpoint events per year
assessed by the number of primary endpoint events during the follow-up period.
Combined endpoint: MACCE
(stroke/systemic embolism/cardiovascular death/myocardial infarction)
Mortality
(including all-cause death, cardiovascular death, non- cardiovascular death, peri-procedural death)
Major bleeding
BARC type 3-5 (according to the BARC (Bleeding Academic Research Consortium) definition for bleeding).
Systemic embolism
assessed by the rate of systemic embolism during the follow-up period.
Ischemic/hemorrhagic stroke including transient ischemic attack
(TIA: defined as neurological deficit of vascular origin lasting ≤24 hours without corresponding brain lesion). Stroke and 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.
Myocardial infarction
Myocardial infarction will be assessed according to the third universal definition of myocardial infarction (Eur Heart J, 2012).
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.
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.
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.
Device-related thrombus
assessed by echocardiographic follow-up.
Full Information
NCT ID
NCT03463317
First Posted
February 16, 2018
Last Updated
July 29, 2021
Sponsor
Charite University, Berlin, Germany
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Atrial Fibrillation Network, Stiftung Institut fuer Herzinfarktforschung
1. Study Identification
Unique Protocol Identification Number
NCT03463317
Brief Title
Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation Compared to Medical Therapy
Acronym
CLOSURE-AF
Official Title
Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation at High Risk of Stroke and Bleeding Compared to Medical Therapy: a Prospective Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Atrial Fibrillation Network, Stiftung Institut fuer Herzinfarktforschung
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Anticoagulation, Left atrial appendage closure, Stroke
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Event-driven group-sequential design, non-inferiority test, if significant followed by superiority test
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1512 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LAA closure group
Arm Type
Experimental
Arm Description
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)
Arm Title
Best medical care group
Arm Type
Active Comparator
Arm Description
No left atrial appendage closure. Treatment with best medical care (NOACs (dabigatran, rivaroxaban, apixaban, edoxaban) or VKA (phenprocoumon, warfarin)
Intervention Type
Device
Intervention Name(s)
CE-mark approved LAA closure devices
Intervention Description
LAA closure with post procedure treatment
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic acid
Other Intervention Name(s)
ASS
Intervention Description
post procedure treatment according to the physicians (recommendation are made in the protocol); oral anticoagulation is not prescribed in this group
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
post procedure treatment according to the physicians (recommendation are made in the protocol); oral anticoagulation is not prescribed in this group
Intervention Type
Drug
Intervention Name(s)
Dabigatran
Other Intervention Name(s)
Pradaxa®
Intervention Description
Patients allocated to the best medical care group receive either NOAC therapy or VKA
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Other Intervention Name(s)
Xarelto®
Intervention Description
Patients allocated to the best medical care group receive either NOAC therapy or VKA
Intervention Type
Drug
Intervention Name(s)
Apixaban
Other Intervention Name(s)
Eliquis®
Intervention Description
Patients allocated to the best medical care group receive either NOAC therapy or VKA
Intervention Type
Drug
Intervention Name(s)
Edoxaban
Other Intervention Name(s)
LIXIANA®
Intervention Description
Patients allocated to the best medical care group receive either NOAC therapy or VKA
Intervention Type
Drug
Intervention Name(s)
Phenprocoumon
Other Intervention Name(s)
Marcumar®
Intervention Description
Patients allocated to the best medical care group receive either NOAC therapy or VKA
Intervention Type
Drug
Intervention Name(s)
Warfarin
Other Intervention Name(s)
Coumadin®
Intervention Description
Patients allocated to the best medical care group receive either NOAC therapy or VKA
Primary Outcome Measure Information:
Title
Primary endpoint (net clinical benefit)
Description
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
follow-up: 24 months
Secondary Outcome Measure Information:
Title
Primary endpoint events per year
Description
assessed by the number of primary endpoint events during the follow-up period.
Time Frame
follow-up: 24 months
Title
Combined endpoint: MACCE
Description
(stroke/systemic embolism/cardiovascular death/myocardial infarction)
Time Frame
follow-up: 24 months
Title
Mortality
Description
(including all-cause death, cardiovascular death, non- cardiovascular death, peri-procedural death)
Time Frame
follow-up: 24 months
Title
Major bleeding
Description
BARC type 3-5 (according to the BARC (Bleeding Academic Research Consortium) definition for bleeding).
Time Frame
follow-up: 24 months
Title
Systemic embolism
Description
assessed by the rate of systemic embolism during the follow-up period.
Time Frame
follow-up: 24 months
Title
Ischemic/hemorrhagic stroke including transient ischemic attack
Description
(TIA: defined as neurological deficit of vascular origin lasting ≤24 hours without corresponding brain lesion). Stroke and 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
follow-up: 24 months
Title
Myocardial infarction
Description
Myocardial infarction will be assessed according to the third universal definition of myocardial infarction (Eur Heart J, 2012).
Time Frame
follow-up: 24 months
Title
Hospitalization for bleeding or cardiovascular event
Description
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
follow-up: 24 months
Title
Changes in cognitive function
Description
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
follow-up: 24 months
Title
Changes in health-related quality of life
Description
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
follow-up: 24 months
Title
Device-related thrombus
Description
assessed by echocardiographic follow-up.
Time Frame
follow-up: 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Signed written informed consent
Documented atrial fibrillation (paroxysmal, persistent, long-standing persistent or permanent)
CHA2DS2VASc-Score ≥ 2
High risk of bleeding under oral anticoagulation or contraindication for (N)OAC therapy, in particular patients with at least one of the following conditions (a-e):
HAS-BLED-Score ≥ 3
Prior intracranial/intraspinal bleed, intraocular bleed compromising vision (BARC: type 3c)
Hemorrhagic/bleeding complication fulfilling BARC type 3a or 3b: gastrointestinal tract, genitourinary tract or respiratory tract bleeding, where the patient is considered to be at a persistently increased risk of bleeding, e.g. the cause of bleeding cannot be successfully eliminated
Chronic kidney disease with eGFR 15-29 ml/min/1.73 m2
Any recurrent bleeding making chronic anticoagulation not feasible
Subject eligible for an LAA occluder device
Age ≥18 years
Willing and capable of providing informed consent, participating in all associated study activities
Key Exclusion Criteria:
Absolute contraindication to acetylsalicylic acid
Comorbidities other than AF requiring chronic (N)OAC therapy, e.g. mechanical heart valve prosthesis
Symptomatic carotid disease (if not treated)
Complex aortic atheroma with mobile plaque (Kronzon classification grade V)
Heart transplant
Active infection or active endocarditis or other infections resulting in bacteremia
Cardiac tumor
Severe liver failure (Child-Pugh class C or liver failure with coagulopathy)
Severe renal failure (GFR <15 ml/min/1.73m2)
Pregnancy or breastfeeding
For female patients of reproductive potential: Unwilling to agree to use a highly effective method of contraception (Pearl index <1) throughout the study period
Subject with participation in another interventional clinical trial during this study or within 30 days before entry into this trial.
Known terminating disease with life expectancy <1 year (including those with end-stage heart failure)
Subjects, who are committed to an institution due to binding official or court order
Subject who is dependent on the Site, the Site Investigator, any sub- investigator, his/her representative and/or the sponsor
Persons who are not proficient in the German language
Acute heart failure within the last 30 days
Cardiac intervention within the last 30 days
Subjects with planned cardiac or non-cardiac surgery or intervention. (These subject can be included 30 days after such intervention / surgery.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johannes J Hartung, MD
Phone
+49 30 450 513 706
Email
johannes-jakob.hartung@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf Landmesser, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Vivantes Klinik Am Urban, Kardiologie
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charité Universitätsmedizin Berlin, CBF, Kardiologie
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Name
Vivantes Klinikum Neukölln, Kardiologie
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Individual Site Status
Recruiting
Facility Name
DRK-Kliniken Berlin Köpenick, Klinik für Innere Medizin - Schwerpunkt Kardiologie und Angiologie
City
Berlin
ZIP/Postal Code
12559
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charité Universitätsmedizin Berlin, CVK, Kardiologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Deutsches Herzzentrum Berlin, Innere Medizin - Kardiologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Brandenburg GmbH, Zentrum für Innere Medizin I
City
Brandenburg
ZIP/Postal Code
14770
Country
Germany
Individual Site Status
Recruiting
Facility Name
Gesundheit Nord gGmbH, Klinikum Links der Weser, Klinik für Kardiologie und Angiologie
City
Bremen
ZIP/Postal Code
28277
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Lippe, Klinik für Kardiologie, Angiologie und Internistische Intensivmedizin
City
Detmold
ZIP/Postal Code
32756
Country
Germany
Individual Site Status
Recruiting
Facility Name
Katholisches Krankenhaus "St. Johann Nepomuk", Klinik für Innere Medizin II - Kardiologie
City
Erfurt
ZIP/Postal Code
99097
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Erlangen, Medizinische Klinik II - Kardiologie und Angiologie
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Name
Alfried Krupp Krankenhaus
City
Essen
ZIP/Postal Code
45131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universität Greifswald, Klinik für Innere Medizin B - Kardiologie
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Name
Asklepios Klinik Barmbek, I. Med. Abteilung - Kardiologie
City
Hamburg
ZIP/Postal Code
22291
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Herford, Med. Klinik III/ Kardiologie
City
Herford
ZIP/Postal Code
32049
Country
Germany
Individual Site Status
Recruiting
Facility Name
Westpfalz-Klinikum GmbH, Klinik für Innere Medizin II - Kardiologie
City
Kaiserslautern
ZIP/Postal Code
67655
Country
Germany
Individual Site Status
Recruiting
Facility Name
UKSH - Campus Kiel, Medizinische Klinik III - Kardiologie, Angiologie, Intensivmedizin
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
UKSH - Universitäres Herzzentrum Lübeck, Medizinische Klinik II - Kardiologie, Angiologie, Intensivmedizin
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsmedizin Mainz, Kardiologie I - Zentrum für Kardiologie
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsmedizin Mannheim, I. Medizinische Klinik - Kardiologie, Angiologie, Intensivmedizin
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Name
Deutsches Herzzentrum München, Klinik an der TU München
City
München
ZIP/Postal Code
80636
Country
Germany
Individual Site Status
Recruiting
Facility Name
LMU Universität München, Medizinische Klinik und Poliklinik I
City
München
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Name
Peter Osypka Herzzentrum München
City
München
ZIP/Postal Code
81379
Country
Germany
Individual Site Status
Recruiting
Facility Name
Städt. Klinikum München GmbH, Klinikum Neuperlach, Klinik für Kardiologie, Pneumologie, intern. Intensivmedizin
City
München
ZIP/Postal Code
81737
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinik Ulm, Klinik für Innere Medizin II - Kardiologie
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Heinrich-Braun-Klinikum Zwickau, Klinik für Innere Medizin I - Kardiologie, Angiologie, Intern. Internsivmedizin
City
Zwickau
ZIP/Postal Code
08060
Country
Germany
Individual Site Status
Recruiting
12. IPD Sharing Statement
Links:
URL
https://closure-af.dzhk.de/
Description
trial website
Learn more about this trial
Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation Compared to Medical Therapy
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