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

November 19, 2018 updated by: Prof Dr Ruediger C. Braun-Dullaeus, University of Magdeburg

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Berka, Germany, 99437
        • Zentralklinik Bad Berka - Klinik für Kardiologie
      • Frankfurt, Germany, 60431
        • CCB im Markus Krankenhaus Frankfurt
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover Zentrum Innere Medizin, Abt. Kardiologie und Angiologie
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Germany, 39104
        • Otto-von-Guericke University Magdeburg, Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24 months

Other Outcome Measures

Outcome Measure
Time Frame
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Magdeburg

Investigators

  • Principal Investigator: Rüdiger C Braun-Dullaeus, Prof, Otto-von-Guericke University Magdeburg Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 21, 2017

Study Completion (Actual)

April 12, 2017

Study Registration Dates

First Submitted

January 15, 2014

First Submitted That Met QC Criteria

January 15, 2014

First Posted (Estimate)

January 17, 2014

Study Record Updates

Last Update Posted (Actual)

November 21, 2018

Last Update Submitted That Met QC Criteria

November 19, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OVGU-014-Kar

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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