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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Magdeburg
Sponsor:
Information provided by (Responsible Party):
Prof Dr Ruediger C. Braun-Dullaeus, University of Magdeburg
ClinicalTrials.gov Identifier:
NCT02039167
First received: January 15, 2014
Last updated: January 19, 2014
Last verified: January 2014
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by University of Magdeburg:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: January 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02039167

Contacts
Contact: Thomas P Rauwolf, Dr ++49 391 6713203 thomas.rauwolf@med.ovgu.de

Locations
Germany
Otto-von-Guericke University Magdeburg, Faculty of Medicine Recruiting
Magdeburg, Saxony-Anhalt, Germany, 39104
Contact: Thomas P Rauwolf, Dr    ++49 0391 6713203    thomas.rauwolf@med.ovgu.de   
Sub-Investigator: Alexander Schmeißer, Prof         
Sub-Investigator: Friederike Großmann         
Sub-Investigator: Samir Said, Dr         
Sub-Investigator: Dave Wenzel         
Sub-Investigator: Thomas Rauwolf, Dr         
Principal Investigator: Rüdiger C Braun-Dullaeus, Prof         
Zentralklinik Bad Berka - Klinik für Kardiologie Not yet recruiting
Bad Berka, Germany, 99437
Contact: Bernward Lauer, Prof.    +493645851201    bernward.lauer@zentralklinik.de   
Principal Investigator: Bernward Lauer, Prof         
Sub-Investigator: Christoph Geller, Prof         
CCB im Markus Krankenhaus Frankfurt Not yet recruiting
Frankfurt, Germany, 60431
Contact: Boris H Schmidt, Dr    +4969951548159    b.schmidt@ccb.de   
Sub-Investigator: Stefano Bordignon, Dr         
Sub-Investigator: Alexander Fürnkranz, Dr         
Sub-Investigator: Boris H Schmidt, Dr         
Principal Investigator: Julian Chun, Dr         
Medizinische Hochschule Hannover Zentrum Innere Medizin, Abt. Kardiologie und Angiologie Not yet recruiting
Hannover, Germany, 30625
Contact: Antje Jürgens    +49511532 6054    Juergens.Antje@mh-hannover.de   
Sub-Investigator: David Duncker, Dr         
Sub-Investigator: Stephan Hohmann, Dr         
Sub-Investigator: Thorben König, Dr         
Principal Investigator: Hanno H Oswald         
Sub-Investigator: Hendrik S Schreyer         
Sub-Investigator: Daniel Sedding, Prof         
Sub-Investigator: Christian Veltmann, PD Dr         
Sponsors and Collaborators
University of Magdeburg
Investigators
Principal Investigator: Rüdiger C Braun-Dullaeus, Prof Otto-von-Guericke University Magdeburg Faculty of Medicine
  More Information

No publications provided

Responsible Party: Prof Dr Ruediger C. Braun-Dullaeus, Prof Dr, University of Magdeburg
ClinicalTrials.gov Identifier: NCT02039167     History of Changes
Other Study ID Numbers: OVGU-014-Kar
Study First Received: January 15, 2014
Last Updated: January 19, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Kidney Diseases
Atrial Fibrillation
Blood Coagulation Disorders
Hemostatic Disorders
Thrombosis
Renal Insufficiency, Chronic
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Hemorrhagic Disorders
Urologic Diseases
Embolism and Thrombosis
Renal Insufficiency

ClinicalTrials.gov processed this record on August 28, 2014