Impact of Steerable Delivery Sheaths on Successful Closure of Left Atrial Appendage With AMULET Dual Mechanism Closure Device (STEER-CLOSE Study)
Kansas City Heart Rhythm Research Foundation
Summary
The novel Amplatzer steerable delivery sheath (Abbott Vascular) is found to be safe and effective in performing LAAO procedure. However, the procedural outcomes have not been compared with the traditional non-steerable fixed curve sheath. In this study investigators aim to compare the outcome of patients undergoing left atrial appendage occlusion with the dual mechanism closure Amulet device using non-steerable fixed curve sheath versus a novel steerable sheath.
Description
Atrial fibrillation (AF) is the most common abnormal heart rhythm associated with substantial morbidity and mortality. It is one of the strongest risk factors of systemic thromboembolism (TE), with stroke being the most serious outcome. Prevention of stroke is the cornerstone of managing AF, which can be achieved either by oral anticoagulation (OAC) or Percutaneous left atrial appendage occlusion (LAAO) in patients who have a contraindication to OAC. Heterogeneity in cardiac chamber size, interatrial septum, LAA anatomy and orientation, operator experience and currently available fixed curve s…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Patients with atrial fibrillation who meets the indication/criteria for left atrial appendage occlusion and undergoing implantation of Amplatzer™ Amulet™ Left Atrial Appendage Occluder device Exclusion Criteria: * Patient been/being implanted with device other than Amplatzer™ Amulet™ Left Atrial Appendage Occluder * Pregnant or breastfeeding patients * Prisoners * Patients not willing to participate in the study
Interventions
- OtherLeft atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.
Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.
Locations (7)
- Menorah Medical CenterOverland Park, Kansas
- Kansas City Heart Rhythm InstituteOverland Park, Kansas
- Overland Park Regional Medical CenterOverland Park, Kansas
- Centerpoint Medical Center ClinicIndependence, Missouri
- Centerpoint Medical CenterIndependence, Missouri
- Research Medical Center ClinicKansas City, Missouri