Back to resultsComparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding. (CLEARANCE)
Primary Purpose
Atrial Fibrillation (AF), Intracranial Bleed
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Percutaneous closure of the LAA (Watchman / Watchman FLX)
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation (AF) focused on measuring Atrial Fibrillation, Intracranial bleeding, LAA occlusion, Anticoagulation
Eligibility Criteria
Inclusion Criteria:
- Signed written informed consent
- Documented atrial fibrillation (paroxysmal, persistent, long-standing persistent or permanent)
- CHA2DS2VASc-Score ≥2
- Status post intracranial bleeding >6 weeks
- Favorable LAA anatomy
- Subject eligible for a LAA occluder device
- Subjects eligible for NOAC therapy
- Age ≥18 years
Exclusion Criteria:
- Comorbidities other than AF requiring chronic (N)OAC therapy, e.g. mechanical heart valve prosthesis, hereditary thrombophilia requiring livelong OAC - recurrent thrombosis
- Symptomatic carotid disease (if not treated)
- Thrombus in the left atrium or left atrial appendage
- Active infection or active endocarditis or other infections resulting in bacteremia
- Functional Impairment (modified ranking scale ≥4 )
- Severe liver failure (Child-Pugh class C or liver failure with coagulopathy)
- Severe renal failure (GFR <15 ml/min/1.73m2)
- Absolute contraindication for long-term NOAC therapy except index ICH
- Pregnancy or breastfeeding
- 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
- Subjects with planned cardiac or non-cardiac surgery or intervention. (These subjects can be included 30 days after intervention / surgery
Sites / Locations
- Universitätsherzzentrum Freiburg - Bad Krozingen
- Klinikum Friedrichshafen GmbHRecruiting
- Universitätsklinikum der J.W. Goethe-Universität Frankfurt
- Knappschaftskrankenhaus Bottrop Gmbh
- Klinikum Chemnitz
- Städtisches Klinikum Friedrichstadt Dresden
- Klinikum St. Georg gGmbHRecruiting
- HBK ZwickauRecruiting
- Katholisches Krankenhaus "St. Johann Nepomuk"
- SRH Wald-Klinikum Gera GmbH
- Rhön Klinikum Bad Neustadt
- Charité - Universitätsmedizin Berlin (CBF)Recruiting
- Evangelisches Klinikum Bethel BielefeldRecruiting
- REGIOMED Klinikum Coburg
- Klinikum Westfalen GmbH DortmundRecruiting
- Heart Center Dresden- UniversityhospitalRecruiting
- Helios Klinikum ErfurtRecruiting
- Universitätsklinikum ErlangenRecruiting
- Elisabeth-Krankenhaus Essen - Contilia Herz- und Gefäßzentrum Essen
- CardioVasculäres Centrum Frankfurt (CVC)
- Asklepios Klinik Nord- HeidbergRecruiting
- Asklepios Klinikum St. Georg
- UKE Hamburg
- Cardiologicum HamburgRecruiting
- Asklepios Klinik Hamburg WandsbekRecruiting
- Asklepios Klinik Hamburg AltonaRecruiting
- Universitätsklinikum Saarland
- Klinikum Ingolstadt GmbHRecruiting
- UniversityhospitalRecruiting
- Westpfalz-Klinikum Kaiserslautern
- Universitätsklinikum Schleswig-Holstein (UKSH) Kiel
- Heart Center LeipzigRecruiting
- Universityhospital LeipzigRecruiting
- Universitätsklinikum Schleswig-Holstein (UKSH) LübeckRecruiting
- Universityhospital MagdeburgRecruiting
- Universityhospital MannheimRecruiting
- Johannes Wesling Klinikum Minden
- Katholisches Klinikum Koblenz (•Montabaur)Recruiting
- Marienhaus Kliniken GmbH Neuwied
- Helios Klinikum PirnaRecruiting
- Klinikum Vest GmbH
- Universitätsklinikum Rostock
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Left Atrial Appendage Occlusion
Best medical therapy for anticoagulation
Arm Description
Percutaneous closure of the LAA by use of CE-mark approved LAA occlusion device Watchman / Watchman FLX
Standard of care (according to current guidelines)
Outcomes
Primary Outcome Measures
Event free survival of the composite of Cardiovascular or unexplained death, Stroke (including ischemic or hemorrhagic stroke), Systemic embolism, Bleeding (BARC type 2-5)
Cardiovascular or unexplained death - Cardiovascular mortality:
Death due to proximate cardiac cause e.g. myocardial infarction, cardiac tamponade, worsening heart failure, or endocarditis
Death caused by non-coronary, non-CNS vascular conditions such as: pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm or other vascular disease
Death from vascular CNS causes from hemorrhagic and ischemic stroke
All procedure-related deaths including those related to a complication of the procedure or treatment for a complication of the procedure
Sudden or unwitnessed death defined as non-traumatic, unexpected fatal event occurring within one hour of the onset of symptoms in an apparently healthy subject. If death is not witness, the definition applies when the victim was in good health 24 hours before the event
Death of unknown cause
Event free survival of the composite of Cardiovascular or unexplained death, Stroke (including ischemic or hemorrhagic stroke), Systemic embolism, Bleeding (BARC type 2-5)
Stroke (including ischemic or hemorrhagic stroke) - A stroke is an acute episode (lasting >24 hours) of focal neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Strokes are characterized as follows:
Ischemic stroke: an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of the central nervous system tissue. Hemorrhage may be a consequence of ischemic stroke. In this situation, the stroke is an ischemic stroke with hemorrhagic transformation and not a hemorrhagic stroke.
Hemorrhagic stroke: an acute episode of focal or global cerebral or spinal dysfunction caused by intraparenchymal, intraventricular, or subarachnoid hemorrhage
Event free survival of the composite of Cardiovascular or unexplained death, Stroke (including ischemic or hemorrhagic stroke), Systemic embolism, Bleeding (BARC type 2-5)
Systemic embolism - Non-CNS systemic embolism is defined as abrupt vascular insufficiency of an extremity or organ associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (e.g., trauma, atherosclerosis, instrumentation). In the presence of atherosclerotic peripheral vascular disease, diagnosis of embolism to the lower extremities should be made with caution and requires angiographic demonstration of abrupt arterial occlusion.
Event free survival of the composite of Cardiovascular or unexplained death, Stroke (including ischemic or hemorrhagic stroke), Systemic embolism, Bleeding (BARC type 2-5)
Bleeding (BARC type 2-5) - Type 2
Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional
Type 3
Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding
Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents
Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision
Type 4
CABG-related bleeding within 48 hours
Type 5
Probable fatal bleeding
Definite fatal bleeding (overt or autopsy or imaging confirmation)
Secondary Outcome Measures
Cardiovascular or unexplained death per year; Stroke per year; Systemic embolism per year; Bleeding per Year
Primary endpoint events per year: Cardiovascular or unexplained death per year; Stroke per year; Systemic embolism per year; Bleeding per Year; The study participants or, if consent has been obtained, relatives are questioned during the visits, if necessary, diagnostic results are obtained;
Combined endpoint: MACCE
Combined endpoint: MACCE (stroke/systemic embolism/cardiovascular death/myocardial infarction)
Mortality
Mortality (including all-cause death, cardiovascular death, non- cardiovascular
Bleeding (BARC type 2-5)
Type 2
Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional
Type 3
Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding
Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents
Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision
Type 4
CABG-related bleeding within 48 hours
Type 5
Probable fatal bleeding
Definite fatal bleeding (overt or autopsy or imaging confirmation)
Systemic embolism
Non-CNS systemic embolism is defined as abrupt vascular insufficiency of an extremity or organ associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (e.g., trauma, atherosclerosis, instrumentation). In the presence of atherosclerotic peripheral vascular disease, diagnosis of embolism to the lower extremities should be made with caution and requires angiographic demonstration of abrupt arterial occlusion.
Ischemic stroke
An acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of the central nervous system tissue. Hemorrhage may be a consequence of ischemic stroke. In this situation, the stroke is an ischemic stroke with hemorrhagic transformation and not a hemorrhagic stroke.
Hemorrhagic stroke
An acute episode of focal or global cerebral or spinal dysfunction caused by intraparenchymal, intraventricular, or subarachnoid hemorrhage
Myocardial infarction
A detailed description of the criteria for myocardial infarction can be found in the study protocol.
Hospitalization for bleeding or cardiovascular event
Hospitalization for bleeding or cardiovascular event
Intracranial bleeding
Intracranial bleeding
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04298723
Brief Title
Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.
Acronym
CLEARANCE
Official Title
Randomized Comparison of Interventional Closure of the Left Atrial Appendage Using a LAA Closure Device Versus Oral Anticoagulation Therapy in Patients With Non-valvular Atrial Fibrillation and Status Post Intracranial Bleeding.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2020 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jena University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Atrial fibrillation is the most common cardiac arrhythmia. In atrial fibrillation, there is a risk that clots can form in the heart, especially in the left atrium. If these clots come loose, there is a risk of stroke. To prevent strokes, patients with atrial fibrillation and status post ICB can be treated with anticoagulants. This medication therapy prevents blood clots from forming in the heart, but can also cause bleeding. Another therapy option is the occlusion of the left atrium. After closure of the left atrium, only a short anticoagulation therapy is necessary until the occluder has healed. The aim of the study is to compare these two treatment approaches. In this study only already approved drugs and occlusion systems will be used.
Detailed Description
Within the current trial, two novel strategies are tested in a randomized fashion in patients with atrial fibrillation and status post intracranial bleeding. Patients with ICH were usually excluded from the large NOAC trials and were also not representatively included in the large Watchman device trials. On the other hand, registries show that there is a significant proportion of patients with status post ICH that were implanted with a LAA closure device in clinical routine, and also there are those patients treated with NOAC due to their high stroke risk, despite the risk of recurrent ICH.
Both therapies, NOAC and LAA closure are effective in preventing stroke in patients with AF at high risk for stroke. Also, for both therapies there is evidence for prevention of bleedings, especially intracranial bleeding events.
Patients within the LAA closure group will have the chance after successful closure of the LAA to quit oral anticoagulation medication and therefore reduce their lifetime risk for bleeding and recurrent bleeding. Patients in the NOAC group are provided with an excellent protection against stroke and a significant reduced bleeding risk compared to Vitamin K antagonist therapy.
The trial will help to develop data and hopefully guidelines for management of patients with AF and status post intracranial bleedings. It may help to give physicians data to therapy patients post ICH adequately and help to reduce mortality rates in those patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation (AF), Intracranial Bleed
Keywords
Atrial Fibrillation, Intracranial bleeding, LAA occlusion, Anticoagulation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
multicenter, prospective, randomized, controlled, non-blinded clinical trial with a two-arm parallel group design
Masking
Outcomes Assessor
Masking Description
CEC blinded DSMB blinded
Allocation
Randomized
Enrollment
530 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Left Atrial Appendage Occlusion
Arm Type
Experimental
Arm Description
Percutaneous closure of the LAA by use of CE-mark approved LAA occlusion device Watchman / Watchman FLX
Arm Title
Best medical therapy for anticoagulation
Arm Type
No Intervention
Arm Description
Standard of care (according to current guidelines)
Intervention Type
Device
Intervention Name(s)
Percutaneous closure of the LAA (Watchman / Watchman FLX)
Intervention Description
LAA closure procedure will be done by experienced operators according to the local SOP. LAA closure will be performed under fluoroscopic and TEE guidance within conscious sedation or general anesthesia. Antibiotic single-shot prophylaxis should be administered peri-procedurally (i.e., cefazolin 2 g). The specific anatomy of the LAA is evaluated and an appropriately sized CE-marked device (WatchmanTM or Watchman FLXTM) is deployed. LAA angiography and TEE imaging is performed to identify optimal positioning of the device and to exclude a relevant leak. Following device deployment, patients will receive a therapy according to the manufacturers IFU, currently Aspirin and clopidogrel for 3 months followed by single Aspirin up to 12 months. Alternatively, 3 months of NOAC followed by Aspirin monotherapy up to 12 months are possible.
Primary Outcome Measure Information:
Title
Event free survival of the composite of Cardiovascular or unexplained death, Stroke (including ischemic or hemorrhagic stroke), Systemic embolism, Bleeding (BARC type 2-5)
Description
Cardiovascular or unexplained death - Cardiovascular mortality:
Death due to proximate cardiac cause e.g. myocardial infarction, cardiac tamponade, worsening heart failure, or endocarditis
Death caused by non-coronary, non-CNS vascular conditions such as: pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm or other vascular disease
Death from vascular CNS causes from hemorrhagic and ischemic stroke
All procedure-related deaths including those related to a complication of the procedure or treatment for a complication of the procedure
Sudden or unwitnessed death defined as non-traumatic, unexpected fatal event occurring within one hour of the onset of symptoms in an apparently healthy subject. If death is not witness, the definition applies when the victim was in good health 24 hours before the event
Death of unknown cause
Time Frame
up to 3 years after randomization
Title
Event free survival of the composite of Cardiovascular or unexplained death, Stroke (including ischemic or hemorrhagic stroke), Systemic embolism, Bleeding (BARC type 2-5)
Description
Stroke (including ischemic or hemorrhagic stroke) - A stroke is an acute episode (lasting >24 hours) of focal neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Strokes are characterized as follows:
Ischemic stroke: an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of the central nervous system tissue. Hemorrhage may be a consequence of ischemic stroke. In this situation, the stroke is an ischemic stroke with hemorrhagic transformation and not a hemorrhagic stroke.
Hemorrhagic stroke: an acute episode of focal or global cerebral or spinal dysfunction caused by intraparenchymal, intraventricular, or subarachnoid hemorrhage
Time Frame
up to 3 years after randomization
Title
Event free survival of the composite of Cardiovascular or unexplained death, Stroke (including ischemic or hemorrhagic stroke), Systemic embolism, Bleeding (BARC type 2-5)
Description
Systemic embolism - Non-CNS systemic embolism is defined as abrupt vascular insufficiency of an extremity or organ associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (e.g., trauma, atherosclerosis, instrumentation). In the presence of atherosclerotic peripheral vascular disease, diagnosis of embolism to the lower extremities should be made with caution and requires angiographic demonstration of abrupt arterial occlusion.
Time Frame
up to 3 years after randomization
Title
Event free survival of the composite of Cardiovascular or unexplained death, Stroke (including ischemic or hemorrhagic stroke), Systemic embolism, Bleeding (BARC type 2-5)
Description
Bleeding (BARC type 2-5) - Type 2
Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional
Type 3
Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding
Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents
Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision
Type 4
CABG-related bleeding within 48 hours
Type 5
Probable fatal bleeding
Definite fatal bleeding (overt or autopsy or imaging confirmation)
Time Frame
up to 3 years after randomization
Secondary Outcome Measure Information:
Title
Cardiovascular or unexplained death per year; Stroke per year; Systemic embolism per year; Bleeding per Year
Description
Primary endpoint events per year: Cardiovascular or unexplained death per year; Stroke per year; Systemic embolism per year; Bleeding per Year; The study participants or, if consent has been obtained, relatives are questioned during the visits, if necessary, diagnostic results are obtained;
Time Frame
up to 3 years after randomization
Title
Combined endpoint: MACCE
Description
Combined endpoint: MACCE (stroke/systemic embolism/cardiovascular death/myocardial infarction)
Time Frame
up to 3 years after randomization
Title
Mortality
Description
Mortality (including all-cause death, cardiovascular death, non- cardiovascular
Time Frame
up to 3 years after randomization
Title
Bleeding (BARC type 2-5)
Description
Type 2
Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional
Type 3
Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding
Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents
Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision
Type 4
CABG-related bleeding within 48 hours
Type 5
Probable fatal bleeding
Definite fatal bleeding (overt or autopsy or imaging confirmation)
Time Frame
up to 3 years after randomization
Title
Systemic embolism
Description
Non-CNS systemic embolism is defined as abrupt vascular insufficiency of an extremity or organ associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (e.g., trauma, atherosclerosis, instrumentation). In the presence of atherosclerotic peripheral vascular disease, diagnosis of embolism to the lower extremities should be made with caution and requires angiographic demonstration of abrupt arterial occlusion.
Time Frame
up to 3 years after randomization
Title
Ischemic stroke
Description
An acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of the central nervous system tissue. Hemorrhage may be a consequence of ischemic stroke. In this situation, the stroke is an ischemic stroke with hemorrhagic transformation and not a hemorrhagic stroke.
Time Frame
up to 3 years after randomization
Title
Hemorrhagic stroke
Description
An acute episode of focal or global cerebral or spinal dysfunction caused by intraparenchymal, intraventricular, or subarachnoid hemorrhage
Time Frame
up to 3 years after randomization
Title
Myocardial infarction
Description
A detailed description of the criteria for myocardial infarction can be found in the study protocol.
Time Frame
up to 3 years after randomization
Title
Hospitalization for bleeding or cardiovascular event
Description
Hospitalization for bleeding or cardiovascular event
Time Frame
up to 3 years after randomization
Title
Intracranial bleeding
Description
Intracranial bleeding
Time Frame
up to 3 years after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed written informed consent
Documented atrial fibrillation (paroxysmal, persistent, long-standing persistent or permanent)
CHA2DS2VASc-Score ≥2
Status post intracranial bleeding >6 weeks
Favorable LAA anatomy
Subject eligible for a LAA occluder device
Age ≥18 years
Exclusion Criteria:
Comorbidities other than AF requiring chronic (N)OAC therapy, e.g. mechanical heart valve prosthesis, hereditary thrombophilia requiring livelong OAC - recurrent thrombosis
Symptomatic carotid disease (if not treated)
Thrombus in the left atrium or left atrial appendage
Active infection or active endocarditis or other infections resulting in bacteremia
Functional Impairment (modified ranking scale ≥4 )
Severe liver failure (Child-Pugh class C or liver failure with coagulopathy)
Pregnancy or breastfeeding
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
Subjects with planned cardiac or non-cardiac surgery or intervention. (These subjects can be included 30 days after intervention / surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sven Möbius-Winkler, Univ. Prof.
Phone
+493641-9324503
Email
sven.moebius-winkler@med.uni-jena.de
First Name & Middle Initial & Last Name or Official Title & Degree
P. Christian Schulze, Prof. Dr.
Email
christian.schulze@med.uni-jena.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Möbius-Winkler, Univ. Prof.
Organizational Affiliation
Department of Internal Medicine I, Jena University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Albrecht Günther, Dr. med.
Organizational Affiliation
Department of Neurology, Jena University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Albrecht Waschke, PD Dr. med.
Organizational Affiliation
Department of Neurosurgery, RHÖN-KLINIKUM Campus Bad Neustadt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
P. Christian Schulze, Prof. Dr.
Organizational Affiliation
Department of Internal Medicine I, Jena University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsherzzentrum Freiburg - Bad Krozingen
City
Freiburg
State/Province
Baden Württemberg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Grundmann, MD
Phone
0761 270-34010
Email
sebastian.grundmann@universitaetsherzzentrum.de
Facility Name
Klinikum Friedrichshafen GmbH
City
Friedrichshafen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
88048
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jochen Wöhrle, MD
Phone
07541 96 251
Email
j.woehrle@klinikum-fn.de
First Name & Middle Initial & Last Name & Degree
Julia Seeger, MD
Facility Name
Universitätsklinikum der J.W. Goethe-Universität Frankfurt
City
Frankfurt am main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariuca Vasa-Nicotera, MD
Phone
069v630180440
Email
mariuca.vasa-nicotera@kgu.de
Facility Name
Knappschaftskrankenhaus Bottrop Gmbh
City
Bottrop
State/Province
Nordrhein Westfahlen
ZIP/Postal Code
46242
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Christ, MD
Phone
02041 15-1051
Email
martin.christ@kk-Bottrop.de
Facility Name
Klinikum Chemnitz
City
Chemnitz
State/Province
Sachsen
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim Ibrahim, MD
Phone
0371 333 422 11
Email
karim-ibrahim@skc.de
Facility Name
Städtisches Klinikum Friedrichstadt Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01067
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Schellong, Prof. Dr.
Email
Sebastian.Schellong@klinikum-dresden.de
Facility Name
Klinikum St. Georg gGmbH
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04129
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norbert Klein, MD
Phone
0341/909 2300
Email
norbert.klein@sanktgeorg.de
Facility Name
HBK Zwickau
City
Zwickau
State/Province
Sachsen
ZIP/Postal Code
08060
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holger H. Sigusch, MD
Phone
0375 512219
Email
holger.sigusch@hbk-zwickau.de
Facility Name
Katholisches Krankenhaus "St. Johann Nepomuk"
City
Erfurt
State/Province
Thüringen
ZIP/Postal Code
99097
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henning Ebelt, MD
Phone
0361 6541111
Email
hebelt@kkh-erfurt.de
Facility Name
SRH Wald-Klinikum Gera GmbH
City
Gera
State/Province
Thüringen
ZIP/Postal Code
07548
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Winterhalter, MD
Phone
0 365 828 1731
Email
winterhalter.studienzentrum@wkg.srh.de
Facility Name
Rhön Klinikum Bad Neustadt
City
Bad Neustadt an der Saale
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hassan Soda, Dr.
Email
Hassan.Soda@campus-nes.de
Facility Name
Charité - Universitätsmedizin Berlin (CBF)
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carsten Skurk, Prof. Dr.
Email
carsten.skurk@charite.de
Facility Name
Evangelisches Klinikum Bethel Bielefeld
City
Bielefeld
ZIP/Postal Code
33617
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wladimir Tschichow, MD
Phone
0049-521-77277672
Email
Wladimir.Tschishow@evkb.de
Facility Name
REGIOMED Klinikum Coburg
City
Coburg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steffen Schnupp, MD
Phone
+49 9561 22 7248
Email
steffen.schnuppl@klinikum-coburg.de
Facility Name
Klinikum Westfalen GmbH Dortmund
City
Dortmund
ZIP/Postal Code
44309
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Farah, Dr.
Email
Ahmed.Farah@klinikum-westfalen.de
Facility Name
Heart Center Dresden- Universityhospital
City
Dresden
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norman Mangner, MD
Phone
+49 351 450 25 297
Email
Norman.Mangner@mailbox.tu-dresden.de
Facility Name
Helios Klinikum Erfurt
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anja Schade, Dr.
Email
anja.schade@helios-gesundheit.de
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joji Kuramatsu, PD Dr.
Email
Joji.Kuramatsu@uk-erlangen.de
Facility Name
Elisabeth-Krankenhaus Essen - Contilia Herz- und Gefäßzentrum Essen
City
Essen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Schmitz, Dr.
Phone
+49 201 897 0
Email
t.schmitz@contilia.de
Facility Name
CardioVasculäres Centrum Frankfurt (CVC)
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Horst Sievert, MD
Phone
0049-69 46 03 13 40
Email
horstsievertmd@aol.com
Facility Name
Asklepios Klinik Nord- Heidberg
City
Hamburg-Nord
ZIP/Postal Code
22417
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Ghanem, MD
Phone
0049-40 181887-3286
Email
a.ghanem@asklepios.com
Facility Name
Asklepios Klinikum St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Willems, Prof. Dr.
Email
s.willems@asklepios.com
Facility Name
UKE Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Götz Thomalla, Prof. Dr.
Email
thomalla@uke.de
Facility Name
Cardiologicum Hamburg
City
Hamburg
ZIP/Postal Code
22041
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Bergmann, MD
Phone
0049-40 682806-74
Email
studie.bergmann@cardiologicum.net
Facility Name
Asklepios Klinik Hamburg Wandsbek
City
Hamburg
ZIP/Postal Code
22043
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tudor C. Pörner, PD Dr.
Email
t.poerner@asklepios.com
Facility Name
Asklepios Klinik Hamburg Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Meincke, Dr.
Email
f.meincke@asklepios.com
Facility Name
Universitätsklinikum Saarland
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Ukena, MD
Phone
06841 1615922
Email
Christian.ukena@uks.eu
Facility Name
Klinikum Ingolstadt GmbH
City
Ingolstadt
ZIP/Postal Code
85049
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silke Gläser
Facility Name
Universityhospital
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sven Möbius-Winkler, MD
Phone
0049-3641-9324503
Email
Sven.Moebius-Winkler@med.uni-jena.de
First Name & Middle Initial & Last Name & Degree
Sissy Grund
Email
sissy.grund@med.uni-jena.de
Facility Name
Westpfalz-Klinikum Kaiserslautern
City
Kaiserslautern
ZIP/Postal Code
67655
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burghard Schumacher, Prof. Dr.
Email
bschumacher@westpfalz-klinikum.de
Facility Name
Universitätsklinikum Schleswig-Holstein (UKSH) Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Saad, PD Dr.
Email
mohammed.saad@uksh.de
Facility Name
Heart Center Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcus Sandri, MD
Phone
+49 341 865252035
Email
marcus.sandri@medizin.uni-leipzig.de
Facility Name
Universityhospital Leipzig
City
Leipzig
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karsten Lenk, MD
Phone
+49 341 9720956
Email
Karsten.Lenk@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Dirk Lindner, MD
Phone
+49 341 9717943
Email
dirk.lindner@medizin.uni-leipzig.de
Facility Name
Universitätsklinikum Schleswig-Holstein (UKSH) Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingo Eitel, Prof. Dr.
Email
Ingo.Eitel@uksh.de
Facility Name
Universityhospital Magdeburg
City
Magdeburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rüdiger CC Braun-Dulleus, MD
Phone
+49-391-67-13203
Email
r.braun-dullaeus@med.ovgu.de
First Name & Middle Initial & Last Name & Degree
Jens Neumann, MD
Phone
+49 391 67 15001
Email
jens.neumann@med.ovgu.de
Facility Name
Universityhospital Mannheim
City
Mannheim
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim Akin, MD
Phone
+49 621383 1492
Email
ibrahim.akin@umm.de
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
ZIP/Postal Code
32429
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcus Wiemer, Prof. Dr.
Email
marcus.wiemer@muehlenkreiskliniken.de
Facility Name
Katholisches Klinikum Koblenz (•Montabaur)
City
Montabaur
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiangtao Yu, MD
Phone
+49 0261 4963132
Email
j.yu@kk-km.de
Facility Name
Marienhaus Kliniken GmbH Neuwied
City
Neuwied
ZIP/Postal Code
56564
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burkhard Hügl, Dr.
Email
Burkhard.Huegl@marienhaus.de
Facility Name
Helios Klinikum Pirna
City
Pirna
ZIP/Postal Code
01796
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steffen Schön, MD
Phone
(03501) 71 18-52 11
Email
Steffen.Schoen@helios-gesundheit.de
Facility Name
Klinikum Vest GmbH
City
Recklinghausen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Weidemann, MD
Phone
02361 56 3401
Email
frank.weidemann@klinikum-vest.de
Facility Name
Universitätsklinikum Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hüseyin Ince, Prof. Dr.
Email
Hueseyin.Ince@med.uni-rostock.de
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.
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