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ATLAS


Title AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
Therapeutic Area Atrial Fibrillation
Principal Investigator Hassan Rastegar, MD
Min Age 18 Years
Gender Any
Contact Angelo DeNofrio
617-636-9458
More Information https://www.clinicaltrials.gov/ct2/show/NCT02701062

Overview

Sometimes, following open heart surgery, patients can develop irregular heart rhythms like atrial fibrillation. Atrial Fibrillation can occur in 30-50% of patients following open heart surgery. This is called, postoperative atrial fibrillation (POAF). POAF and related stroke/TIAs impact dying, and quality of life (QoL) for patients undergoing structural heart disease procedures. Usually these heart rhythms straighten out within your hospital stay but are typically treated with some drugs to decrease the ability of you blood to clot. Some people that have a high risk of bleeding cannot take blood thinners. This study is collecting information on the treatment of those subjects that develop POAF. This research study is also comparing how LAA closure impacts the physical health and quality of life (QoL) versus not having it closed in a special group of people, The left atrial appendage (LAA) is a small sac located on the upper chamber of your heart. This sac is thought to be the site where blood clots form and is believed to be associated with a significant risk of stroke/TIA in patients with specific risk factors like age, hypertension, atrial fibrillation, and diabetes. 

Study Details

Inclusion Criteria

  • Scheduled for a non-mechanical valve or CABG procedure where direct access to the LAA is expected
  • No documented preoperative atrial fibrillation
  • CHA2DS2-VASc and HASBLED score of >2

Exclusion Criteria

  • Ejection fraction <30
  • Require anticoagulation therapy
  • Mechanical heart value or other anticipated or current requirement for anticoagulation therapy during the post-operative (30 day) period

Study Requirements

Your participation in this study will last for approximately one year from the date of your heart surgery if you develop post-operative atrial fibrillation (POAF) or if you receive the AtriClip. If you do not develop POAF and you do not receive the AtriClip, your participating ends after the 30-day follow-up visit (Visit 4). If you develop POAF and/or receive an AtriClip, there are 6 study visits that include: quality of life questionnaires, heart rating questionnaire, your surgical procedure, and 2 phone call visits.