Heart Study on a Left Atrial Appendage Closure Device to Reduce the Risk of Stroke

What we are studying

Normally, electrical signals from the upper chambers of the heart (atria) travel to the lower chambers of the heart (ventricles) and cause them to beat in a regular way. During atrial fibrillation, the electrical signals in your heart are not normal and cause the upper chambers of the heart to beat too fast and irregularly. This irregular beating of the heart leads to a slowing of the blood flow in the upper chambers of the heart. In the left upper chamber, there is a small pouch called the left atrial appendage (LAA). Slowing of blood, especially in the LAA, may cause blood clots to form. Blood clots can move from the LAA and travel to the brain, causing a stroke or transient ischemic attack (TIA), also called a mini-stroke. These blood clots can also travel to other parts of the body and block blood vessels. The Amulet device could be beneficial to people with nonvalvular atrial fibrillation because it may lower the chance of a new blood clot forming and moving from their heart’s LAA to other parts of their body.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Diagnosed with non-valvular atrial fibrillation
  • Increased risk for stroke or systemic embolism
  • Recommended for anticoagulation therapy
  • Suitable to take warfarin
  • Have an appropriate reason to seek an alternative to taking warfarin or other anticoagulation medications
  • Suitable for LAA closure
  • Able to follow the required medication routes after receiving a device
  • Able and willing to return for study follow-up visits and testing

What is involved

  • 5 follow-up visits to clinic that will take approximately half a day
  • 5 telelphone visits
  • 4 quality of life questionnaires
  • At least 2 TEE
  • 5 year commitment



Contact Information

Study Coordinator
Sandra Soots
(336) 716-7035
Principal Investigator
Sean Whalen

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.