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

StatusNot Yet Recruiting
PhaseNot applicable
Started2026-01
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 4 times since 2022-07-14; most recent filed 2025-08-27. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2025-08-27
Amendment Study Status v4
2024-10-25
Amendment Study Status v3
2024-10-14
Amendment Study Status v2
2023-03-08
Amendment Study Status v1
2022-07-14
Original filing
Trial Details
NCT Number NCT05464511
Lead Sponsor Kansas City Heart Rhythm Research Foundation
Collaborators: Kansas City Heart Rhythm Institute
Conditions Atrial Fibrillation, Stroke
Enrollment 300 participants
Start Date 2026-01
Primary Completion 2026-10 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-08-28