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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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 moreAwards & 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.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have atrial fibrillation and are having a specific heart device implanted.You have a medical device implanted other than the Amplatzer™ Amulet™ Left Atrial Appendage Occluder.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with Amulet device using non-steerable fixed curve sheath
- Group 2: Patients with Amulet device using a novel steerable sheath
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.