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

• Status: Active, not recruiting
• Trial end date: 2020-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Christopher Ellis; Vanderbilt University Medical Center
• Collaborator: Boehringer Ingelheim
• Treatments: Aspirin; Dabigatran

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.