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Efficacy of Short Term Dabigatran Etexilate Followed by Aspirin Monotherapy After LAA (Left Atrial Appendage) Device Closure (the DEA-LAA Study). (DEA-LAA)

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ClinicalTrials.gov Identifier: NCT03539055
Recruitment Status : Enrolling by invitation
First Posted : May 28, 2018
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Christopher Ellis, Vanderbilt University Medical Center

Brief Summary:
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.) to prevent device related thrombus.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device Related Thrombus Left Atrial Appendage Thrombosis Watchman LAA Closure Device Drug: Dabigatran Etexilate Oral Capsule Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective single arm intervention of dabigatran etexilate with aspirin for 90 days following Watchman LAA device closure to prevent device related thrombus (DRT)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Short Term Dabigatran Etexilate Followed by Aspirin Monotherapy After LAA (Left Atrial Appendage) Device Closure (the DEA-LAA Study).
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : August 31, 2020


Arm Intervention/treatment
Experimental: Treatment arm

Dabigatran 75 or 150mg BID x 90 days plus ASA 81mg daily.

Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.)

Drug: Dabigatran Etexilate Oral Capsule
Oral use of Dabigatran etexilate for 90 days BID per product labeling for dosage to reduce incidence of device related thrombus after implantation of a Watchman LAA device.
Other Name: Pradaxa




Primary Outcome Measures :
  1. Device related thrombus (DRT) at 90 days [ Time Frame: 90 days ]
    Transesophageal echocardiogram or CT angiography determined presence of DRT at 90 days

  2. Device related thrombus (DRT) at 1 year [ Time Frame: 1 year ]
    Transesophageal echocardiogram or CT angiography determined presence of DRT at 1 year post implant


Secondary Outcome Measures :
  1. Major bleeding [ Time Frame: 90 days ]
    Major adverse bleeding on dabigatran etexilate at 90 days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female sex, age >18 years.
  2. CHADS2 Vascular score of 3-9 and HAS BLED score 2 or higher meeting CMS coverage criteria for Watchman LAA closure device implantation.
  3. Able to give informed consent.
  4. Life expectancy of > 1year in the judgment of the implanting physician and shared decision-making physician.

Exclusion Criteria:

  1. Unable to give informed consent
  2. History of confirmed allergy to dabigatran etexilate
  3. Active cerebral bleeding, or active non-cerebral bleeding requiring blood transfusions (any absolute contra-indications to anti-coagulation).
  4. History of intraocular, spinal, retroperitoneal or a traumatic intra-articular bleeding unless the causative factor has been permanently eliminated or repaired (e.g. by surgery)
  5. Gastrointestinal (GI) haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated (e.g. by surgery)
  6. Major bleeding episode (reduction in the haemoglobin level of at least 2g/dL, transfusion of at least two units of blood, or symptomatic bleeding in a critical area or organ) including life-threatening bleeding episode (symptomatic intracranial bleeding, bleeding with a decrease in the haemoglobin level of at least 5g/dL or bleeding requiring transfusion of at least 4 units of blood or inotropic agents or necessitating surgery) in one month prior to screening visit
  7. Intolerance to dabigatran, if medication naïve, or other contra-indications as per the USPI, including ESRD on hemodialysis or GFR < 15ml/min, or concomitant use of rifampin.
  8. History of non-compliance, inability to follow-up.
  9. Pre-menopausal women (last menstruation ≤ 1 year prior to screening) who are not surgically sterile.
  10. Ischemic stroke or hemorrhagic stroke within 90 days of LAA placement.
  11. Anatomy unsuitable for LAA closure (incomplete surgical LAA ligation without suitable anatomy for Watchman placement. LAA ostial measurements >31mm, or <17mm in all views).
  12. Requires long-term oral anticoagulation therapy for a condition other than atrial fibrillation.
  13. ASA allergy, or confirmed allergy to nickel.
  14. Prior PFO or ASD closure device or prosthetic or mechanical heart valve.
  15. Acute MI within 90 days.
  16. Platelets <50,000 at time of Watchman LAAC implantation.
  17. Active endocarditis.
  18. Planning for endocardial catheter AF or left atrial ablation within 90 days of Watchman implantation.

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 ClinicalTrials.gov identifier (NCT number): NCT03539055


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Christopher Ellis
Boehringer Ingelheim
Investigators
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Principal Investigator: Christopher E Ellis, MD Vanderbilt University Medical Center

Publications:

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Responsible Party: Christopher Ellis, Associate Professor of Medicine, Cardiac Electrophysiology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03539055     History of Changes
Other Study ID Numbers: DEA-LAA
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: RedCap database, central to primary center, online, web based and HIPAA compliant. Password protected and encrypted database.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Christopher Ellis, Vanderbilt University Medical Center:
DRT
Device related thrombus
Dabigatran etexilate
Aspirin
Watchman
Additional relevant MeSH terms:
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Atrial Fibrillation
Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Aspirin
Dabigatran
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Anticoagulants