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Procedure

Left Atrial Appendage Occlusion with AMULET using Steerable Delivery Sheaths for Stroke and Atrial Fibrillation

N/A
Waitlist Available
Led By Dhanunjaya Lakkireddy
Research Sponsored by Kansas City Heart Rhythm Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial finds that the Amplatzer steerable delivery sheath is safe and effective for left atrial appendage occlusion, but no better than the traditional fixed curve sheath.

Who is the study for?
This trial is for patients with atrial fibrillation who need a left atrial appendage occlusion, specifically using the Amplatzer™ Amulet™ device. It's not for prisoners, pregnant or breastfeeding individuals, those unwilling to participate, or patients using different devices.
What is being tested?
The study compares two methods of closing off the left atrial appendage in heart patients: one uses a traditional non-steerable sheath and the other uses a new steerable sheath with the aim to see if one results in better outcomes.
What are the potential side effects?
While specific side effects are not listed here, procedures involving heart devices can include risks such as bleeding, infection at the site of implantation, damage to heart structures, and potential complications related to anesthesia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Need for Pericardiocentesis
Number of participants with Acute Closure of Left Atrial Appendage
Number of patients with Cardiac Perforation
Secondary study objectives
Closure Rates
Number of device repositions
Number of devices
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Patients with Amulet device using non-steerable fixed curve sheathActive Control1 Intervention
Patients undergoing left atrial appendage occlusion with the dual mechanism closure Amulet device using non-steerable fixed curve sheath.
Group II: Patients with Amulet device using a novel steerable sheathActive Control1 Intervention
Patients undergoing left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.

Find a Location

Who is running the clinical trial?

Kansas City Heart Rhythm InstituteOTHER
8 Previous Clinical Trials
1,446 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
369 Patients Enrolled for Atrial Fibrillation
Kansas City Heart Rhythm Research FoundationLead Sponsor
28 Previous Clinical Trials
13,598 Total Patients Enrolled
14 Trials studying Atrial Fibrillation
5,834 Patients Enrolled for Atrial Fibrillation
Dhanunjaya LakkireddyPrincipal InvestigatorKansas City Heart Rhythm Institute
12 Previous Clinical Trials
8,886 Total Patients Enrolled
6 Trials studying Atrial Fibrillation
2,926 Patients Enrolled for Atrial Fibrillation

Media Library

Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05464511 — N/A
Atrial Fibrillation Research Study Groups: Patients with Amulet device using non-steerable fixed curve sheath, Patients with Amulet device using a novel steerable sheath
Atrial Fibrillation Clinical Trial 2023: Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath Highlights & Side Effects. Trial Name: NCT05464511 — N/A
Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05464511 — N/A
~200 spots leftby Oct 2025
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