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

NCT05464511 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-08-28

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Left 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.

Sponsors & Collaborators

  • Kansas City Heart Rhythm Institute

    collaborator OTHER

  • Kansas City Heart Rhythm Research Foundation

    lead OTHER

Principal Investigators

  • Dhanunjaya Lakkireddy · Kansas City Heart Rhythm Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05464511 on ClinicalTrials.gov