CI

At a glance

ClinicalIndex Comparison Record
N/ANot Yet Recruiting· 300 target
Drug / intervention
Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05464511
NCT05464511N/ANot Yet Recruiting

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·interventional·Posted Jul 19, 2022·Updated Aug 28, 2025

In Brief

A clinical study evaluating Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath. for Atrial Fibrillation and Stroke. Not yet recruiting, targeting 300 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ANot Yet Recruiting
20232024202520262027
First PostedJul 19, 2022
Enrollment StartJan 1, 2026
Primary CompletionOct 1, 2026
Study CompletionDec 1, 2026
TodayJul 1, 2026
Enrollment to primary: 9 monthsPosted 3.9 years agoPrimary completion in 3 months

Interventions

Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.other

Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.