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

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
Kansas City Heart Rhythm Research Foundation
Study ID
NCT05464511
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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 Dates

Start date
Jan 31, 2026
Status verified
Oct 2024
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • No Intervention: Patients with Amulet device using non-steerable fixed curve sheath
    Patients undergoing left atrial appendage occlusion with the dual mechanism closure Amulet device using non-steerable fixed curve sheath.
  • Active Comparator: Patients with Amulet device using a novel steerable sheath
    Patients undergoing left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.

Primary Outcome Measure

Number of participants with Acute Closure of Left Atrial Appendage [ Time Frame: 1 day ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Kansas City Heart Rhythm InstituteOverland ParkKansas66211-
Menorah Medical CenterOverland ParkKansas66209-
Overland Park Regional Medical CenterOverland ParkKansas66215-
Centerpoint Medical CenterIndependenceMissouri64057-
Centerpoint Medical Center ClinicIndependenceMissouri64057-
Research Medical CenterKansas CityMissouri64032-
Research Medical Center ClinicKansas CityMissouri64032-

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