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Left Atrial Appendage Occlusion vs. Usual Care in Patients With Atrial Fibrillation and Severe Chronic Kidney Disease (WatchAFIB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02039167
Recruitment Status : Terminated (The recruitment rate was very poor. The study was stopped by amendment on 2015-08-28.)
First Posted : January 17, 2014
Last Update Posted : November 21, 2018
Information provided by (Responsible Party):
Prof Dr Ruediger C. Braun-Dullaeus, University of Magdeburg

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.

Condition or disease Intervention/treatment Phase
Blood Coagulation Disorders Atrial Fibrillation Thrombosis of Left Atrial Appendage Chronic Kidney Disease Stage 4 Chronic Kidney Disease Stage 5 Device: Left atrial appendage occlusion Not Applicable

Detailed Description:

Open, randomized, controlled, multicenter clinical investigation. Transesophageal echocardiography (TEE) for all patients within 14 days of the Enrolment Visit. Patients randomized to oral anticoagulation (OAC) will receive standard of care (SOC) vitamin K antagonist treatment throughout the 24 months clinical investigation period, managed by the primary care physician, with the goal of achieving and maintaining an INR of 2-3 (INR monitoring by the primary care physician every two weeks throughout study period).

Patients randomized to the WATCHMAN device will undergo device implantation within 48 hours of the screening TEE and after confirmation of INR ≤ 1.7 in the catheterization laboratory with a subsequent hospitalization for 24-48 hours.

Concomitant treatment with Aspirin/Clopidogrel (managed by the patient's primary care physician) will be initiated on the day prior to device implantation, and will be continued for 6 months after the procedure, at which time Clopidogrel will be discontinued; administration of Aspirin will be continued indefinitely.

Follow-up visits for all patients will take place on Day 45, and at Month 6, Month 12 and Month 24 (End of Study). Routine safety and efficacy assessments at each visit will be the same for all patients regardless of treatment group.

Follow-up- visits at day 45, months 6, 12 and 24. Patients randomized to the WATCHMAN device will have additional TEE imaging performed at the Day 45 and Month 6 visits.

An independent Data Monitoring Committee will monitor safety. A blinded and independent Endpoint Committee will evaluate end-points throughout the entire study period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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)
Study Start Date : January 2014
Actual Primary Completion Date : March 21, 2017
Actual Study Completion Date : April 12, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Left atrial appendage occlusion
Percutaneous left atrial appendage closure using the WATCHMAN device.
Device: Left atrial appendage occlusion
Percutaneous left atrial appendage closure using the WATCHMAN device.

No Intervention: OAC with a vitamin K antagonist
Oral anticoagulants (OAC) as Standard of Care (SOC) provided by primary care physician

Primary Outcome Measures :
  1. Frequency of occurrence of moderate and major bleedings (Type 2 to Type 5 according to the Bleeding Academic Research Consortium (BARC) definitions) [ Time Frame: 24 months ]

Secondary Outcome Measures :
  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) [ Time Frame: 24 months ]

Other Outcome Measures:
  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 [ Time Frame: 24 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02039167

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Otto-von-Guericke University Magdeburg, Faculty of Medicine
Magdeburg, Saxony-Anhalt, Germany, 39104
Zentralklinik Bad Berka - Klinik für Kardiologie
Bad Berka, Germany, 99437
CCB im Markus Krankenhaus Frankfurt
Frankfurt, Germany, 60431
Medizinische Hochschule Hannover Zentrum Innere Medizin, Abt. Kardiologie und Angiologie
Hannover, Germany, 30625
Sponsors and Collaborators
University of Magdeburg
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Principal Investigator: Rüdiger C Braun-Dullaeus, Prof Otto-von-Guericke University Magdeburg Faculty of Medicine
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Responsible Party: Prof Dr Ruediger C. Braun-Dullaeus, Prof Dr, University of Magdeburg Identifier: NCT02039167    
Other Study ID Numbers: OVGU-014-Kar
First Posted: January 17, 2014    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Atrial Fibrillation
Hemostatic Disorders
Blood Coagulation Disorders
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Urologic Diseases
Renal Insufficiency
Embolism and Thrombosis
Vascular Diseases
Hematologic Diseases
Hemorrhagic Disorders