Atrial Fibrillation Clinical Trial
— WatchAFIBOfficial title:
WATCH Bleeding Episodes After Left Atrial Appendage Occlusion Versus Usual Care in Patients With Atrial FIBrillatIon and Severe to eNd-stage Chronic Kidney Disease (WatchAFIB in CKD)
Verified date | November 2018 |
Source | University of Magdeburg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the superiority of left atrial appendage occlusion in comparison to oral anticoagulation with a vitamin K antagonist (INR 2-3) related to the frequency of occurrence of at least one bleeding classified as moderate or major within 24 months.
Status | Terminated |
Enrollment | 14 |
Est. completion date | April 12, 2017 |
Est. primary completion date | March 21, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF), documented by electrocardiography performed at screening or within the prior 6 months - Indication for oral anticoagulation as assessed by CHA2DS2-VASc-Score (= 2) - Severe to end-stage chronic kidney disease (eGFR < 30 ml/min as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula) - 18 to 80 years, inclusive - Life expectancy of at least 2 years - Negative pregnancy test for women - Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent - Written informed consent Exclusion Criteria: - AF due to a reversible cause or a singular occurrence of AF - Conditions other than AF that require anticoagulation - Transient ischemic attack or stroke within previous 3 months - A need for Aspirin (at a dose of > 162.5 mg/day) or for both Aspirin and Clopidogrel/other antiplatelet drugs (daily administration) other than for clinical investigation - Contraindications or allergies to vitamin K antagonists, Aspirin or Clopidogrel - Previous closure (surgical, interventional) of the left atrial appendage (LAA) - Previous closure of atrial septal defect (ASD) / persistent foramen ovale (PFO) - Active internal bleeding - Thrombocytopenia (< 100,000 platelets/mm3) - History of or planned organ transplantation - Planned Mitra Clip or transcatheter aortic valve implantation (TAVI) intervention - Planned cardiac surgery - History of intracranial, intraocular or retroperitoneal bleeding - Severe GI-bleeding within the last 3 months - Hemorrhagic gastro-intestinal diseases (e.g., ulcerative colitis) - History of or condition associated with increased bleeding risk - Uncontrolled arterial hypertension - Heparin-induced thrombocytopenia type II - Known inherited coagulation disorders - Severe liver dysfunction (spontaneous INR > 1.5) or liver cirrhosis = CHILD B - Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) - Women who are planning to become pregnant, or who are breastfeeding - Active infection of any kind Transesophageal echocardiography (TEE) Exclusion Criteria - Intracardiac thrombus or dense spontaneous echo contrast as visualized by TEE (with use of sonovue in suspicious cases) - Significant mitral valve stenosis - Any congenital heart disease, including atrial septal defect - Pericardial effusion during ECHO assessment of > 2 mm - Cardiac tumor |
Country | Name | City | State |
---|---|---|---|
Germany | Zentralklinik Bad Berka - Klinik für Kardiologie | Bad Berka | |
Germany | CCB im Markus Krankenhaus Frankfurt | Frankfurt | |
Germany | Medizinische Hochschule Hannover Zentrum Innere Medizin, Abt. Kardiologie und Angiologie | Hannover | |
Germany | Otto-von-Guericke University Magdeburg, Faculty of Medicine | Magdeburg | Saxony-Anhalt |
Lead Sponsor | Collaborator |
---|---|
University of Magdeburg |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Time to occurrence of first moderate and major bleeding as well as to occurrence of stroke (ischemic or hemorrhagic) according to the modified Rankin scale | 24 months | ||
Primary | Frequency of occurrence of moderate and major bleedings (Type 2 to Type 5 according to the Bleeding Academic Research Consortium (BARC) definitions) | 24 months | ||
Secondary | Frequency of at least one occurrence of a combined endpoint of moderate or major bleeding and/or severe cardiovascular adverse events (stroke, cardiac infarction, thrombosis, death) | 24 months |
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