Study Stopped
The recruitment rate was very poor. The study was stopped by amendment on 2015-08-28.
Left Atrial Appendage Occlusion vs. Usual Care in Patients With Atrial Fibrillation and Severe Chronic Kidney Disease
WatchAFIB
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)
1 other identifier
interventional
14
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2014
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 15, 2014
CompletedFirst Posted
Study publicly available on registry
January 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2017
CompletedNovember 21, 2018
November 1, 2018
3.2 years
January 15, 2014
November 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Other Outcomes (1)
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
Study Arms (2)
Left atrial appendage occlusion
ACTIVE COMPARATORPercutaneous left atrial appendage closure using the WATCHMAN device.
OAC with a vitamin K antagonist
NO INTERVENTIONOral anticoagulants (OAC) as Standard of Care (SOC) provided by primary care physician
Interventions
Percutaneous left atrial appendage closure using the WATCHMAN device.
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- 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)
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Otto-von-Guericke University Magdeburg, Faculty of Medicine
Magdeburg, Saxony-Anhalt, 39104, Germany
Zentralklinik Bad Berka - Klinik für Kardiologie
Bad Berka, 99437, Germany
CCB im Markus Krankenhaus Frankfurt
Frankfurt, 60431, Germany
Medizinische Hochschule Hannover Zentrum Innere Medizin, Abt. Kardiologie und Angiologie
Hanover, 30625, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rüdiger C Braun-Dullaeus, Prof
Otto-von-Guericke University Magdeburg Faculty of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof Dr
Study Record Dates
First Submitted
January 15, 2014
First Posted
January 17, 2014
Study Start
January 1, 2014
Primary Completion
March 21, 2017
Study Completion
April 12, 2017
Last Updated
November 21, 2018
Record last verified: 2018-11