Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Atrial Fibrillation
• Age: Between 18 years - 100 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Has documented non-valvular atrial fibrillation
  2. Has a calculated CHA2DS2-VASc score of 2 or greater for men and 3 or greater for women
  3. Deemed to be suitable for the protocol defined pharmacologic regimens in both the test and control arms
  4. Able to understand and willing to provide written informed consent to participate in the trial
  5. Able and willing to return for required follow-up visits and examinations

  
  

You may not be eligible for this study if the following are true:

• 1. Subjects who are currently enrolled in another investigational study
  2. Requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction
  3. Contraindicated or allergic to oral anticoagulation medication and/or aspirin
  4. Indicated for chronic P2Y12 platelet inhibitor therapy
  5. Had or is planning to have any cardiac or non-cardiac intervention or surgical procedure within 30 days prior to or 60 days after implant
  6. Had a prior stroke or transient ischemic attack (TIA) within the 30 days
  7. Had a prior major bleeding event per ISTH definition within the 30 days
  8. Has an active bleed
  9. Has a reversible cause of AF or transient AF
  10. Is absent of a left atrial appendage (LAA) or the LAA is surgically ligated
  11. Has had a myocardial infarction (MI) documented in the clinical record as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention,
  12. Has a history of atrial septal repair or has an ASD/PFO device
  13. Has an implanted mechanical valve prosthesis in any position
  14. Has a known contraindication to percutaneous catheterization procedure
  15. Has a known contraindication to TEE
  16. Has a cardiac tumor
  17. Has signs/symptoms of acute or chronic pericarditis
  18. Participants who have an active infection
  19. Those with evidence of tamponade physiology
  20. Participants who has New York Heart Association Class IV Congestive Heart Failure at the time of enrollment
  21. Those who are pregnant or plans to become pregnant
  22. has documented life expectancy of less than 3 years