Impact of Steerable Delivery Sheaths on Successful Closure of LA A With AMULET

Starting soon · Not applicable

Conditions studied: Atrial Fibrillation, Stroke

In brief

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.

Key facts

Study ID

NCT05464511

Run by

Kansas City Heart Rhythm Research Foundation

People needed

300

Starts

2026-01-01

Expected to finish

2026-12-01

Last updated by the study team

2025-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Menorah Medical Center — Overland Park, Kansas, United States
• Kansas City Heart Rhythm Institute — Overland Park, Kansas, United States
• Overland Park Regional Medical Center — Overland Park, Kansas, United States
• Centerpoint Medical Center Clinic — Independence, Missouri, United States
• Centerpoint Medical Center — Independence, Missouri, United States
• Research Medical Center Clinic — Kansas City, Missouri, United States
• Research Medical Center — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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