Testing a steerable sheath for closing the heart's left atrial appendage in atrial fibrillation
Compares two catheter sheaths when closing the left atrial appendage in atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Impact of Steerable Delivery Sheaths on Successful Closure of LA A With AMULET
Key facts
- Where
- Independence, Kansas City, and Overland Park, United StatesSee the 7 sites
Where in United States
- Centerpoint Medical CenterIndependence, United StatesNo longer taking part
- Centerpoint Medical Center ClinicIndependence, United StatesNo longer taking part
- Research Medical CenterKansas City, United StatesNo longer taking part
- Research Medical Center ClinicKansas City, United StatesNo longer taking part
- Kansas City Heart Rhythm InstituteOverland Park, United StatesNo longer taking part
- Menorah Medical CenterOverland Park, United StatesNo longer taking part
- Overland Park Regional Medical CenterOverland Park, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kansas City Heart Rhythm Research Foundation
- Trial code
- NCT05464511
- Record updated
- 28 August 2025
- Original description
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.Read full original descriptionShow less
Impact of Steerable Delivery Sheaths on Successful Closure of Left Atrial Appendage With AMULET Dual Mechanism Closure Device (STEER-CLOSE Study)
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.
Inclusion: 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: 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.