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

Korábbi kezelés

• 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)
• Pre-menopausal women (last menstruation ≤ 1 year prior to screening) who are not surgically sterile.
• Anatomy unsuitable for LAA closure (incomplete surgical LAA ligation without suitable anatomy for Watchman placement. LAA ostial measurements >31mm, or <17mm in all views).
• Prior PFO or ASD closure device or prosthetic or mechanical heart valve.

Más betegség

• History of confirmed allergy to dabigatran etexilate
• Active cerebral bleeding, or active non-cerebral bleeding requiring blood transfusions (any absolute contra-indications to anti-coagulation).
• 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)
• History of non-compliance, inability to follow-up.
• Ischemic stroke or hemorrhagic stroke within 90 days of LAA placement.
• Requires long-term oral anticoagulation therapy for a condition other than atrial fibrillation.
• ASA allergy, or confirmed allergy to nickel.

Laborértékek

• 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
• 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.
• Platelets <50,000 at time of Watchman LAAC implantation.

Egyéb

• Unable to give informed consent
• Acute MI within 90 days.
• Active endocarditis.
• Planning for endocardial catheter AF or left atrial ablation within 90 days of Watchman implantation.

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