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

Primary Purpose

Blood Coagulation Disorders, Atrial Fibrillation, Thrombosis of Left Atrial Appendage

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Left atrial appendage occlusion
Sponsored by
University of Magdeburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Coagulation Disorders

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Left atrial appendage occlusion

OAC with a vitamin K antagonist

Arm Description

Percutaneous left atrial appendage closure using the WATCHMAN device.

Oral anticoagulants (OAC) as Standard of Care (SOC) provided by primary care physician

Outcomes

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)

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)

Full Information

First Posted
January 15, 2014
Last Updated
November 19, 2018
Sponsor
University of Magdeburg
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1. Study Identification

Unique Protocol Identification Number
NCT02039167
Brief Title
Left Atrial Appendage Occlusion vs. Usual Care in Patients With Atrial Fibrillation and Severe Chronic Kidney Disease
Acronym
WatchAFIB
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 Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
The recruitment rate was very poor. The study was stopped by amendment on 2015-08-28.
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 21, 2017 (Actual)
Study Completion Date
April 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Magdeburg

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Coagulation Disorders, Atrial Fibrillation, Thrombosis of Left Atrial Appendage, Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 5

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Left atrial appendage occlusion
Arm Type
Active Comparator
Arm Description
Percutaneous left atrial appendage closure using the WATCHMAN device.
Arm Title
OAC with a vitamin K antagonist
Arm Type
No Intervention
Arm Description
Oral anticoagulants (OAC) as Standard of Care (SOC) provided by primary care physician
Intervention Type
Device
Intervention Name(s)
Left atrial appendage occlusion
Intervention Description
Percutaneous left atrial appendage closure using the WATCHMAN device.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rüdiger C Braun-Dullaeus, Prof
Organizational Affiliation
Otto-von-Guericke University Magdeburg Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Otto-von-Guericke University Magdeburg, Faculty of Medicine
City
Magdeburg
State/Province
Saxony-Anhalt
ZIP/Postal Code
39104
Country
Germany
Facility Name
Zentralklinik Bad Berka - Klinik für Kardiologie
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Facility Name
CCB im Markus Krankenhaus Frankfurt
City
Frankfurt
ZIP/Postal Code
60431
Country
Germany
Facility Name
Medizinische Hochschule Hannover Zentrum Innere Medizin, Abt. Kardiologie und Angiologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany

12. IPD Sharing Statement

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

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