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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
Patients with atrial fibrillation who meet the indication/criteria for left atrial appendage occlusion and are undergoing implantation of Amplatzer™ Amulet™ Left Atrial Appendage Occluder device
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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.

Eligible Conditions
  • Stroke
  • Atrial Fibrillation

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have atrial fibrillation and are having a specific heart device implanted.

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

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

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
1 Trials studying Stroke
246 Patients Enrolled for Stroke
Kansas City Heart Rhythm Research FoundationLead Sponsor
24 Previous Clinical Trials
9,072 Total Patients Enrolled
3 Trials studying Stroke
398 Patients Enrolled for Stroke
Dhanunjaya LakkireddyPrincipal InvestigatorKansas City Heart Rhythm Institute
10 Previous Clinical Trials
6,286 Total Patients Enrolled

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
Stroke Research Study Groups: Patients with Amulet device using non-steerable fixed curve sheath, Patients with Amulet device using a novel steerable sheath
Stroke 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What outcome is this experiment aiming to achieve?

"The primary endpoint of this research, assessed within a day, is Need for Pericardiocentesis. Secondary endpoints include the Number of Device Repositions that were done during the study period, the Quantity of Patients with Transient Ischemic Attack (TIA) or Cerebrovascular Accident (CVA) in 6 months after treatment completion and finally Closure Rates which are monitored over 45 days post Left Atrial Appendage closure (<= 3mm)."

Answered by AI

Is this research endeavor presently enrolling participants?

"The records from clinicaltrials.gov indicate that this particular trial is not presently recruiting participants, even though it was initially launched on August 1st 2022 and its data was last modified on July 14th 2022. Fortunately, there are currently 1,471 other studies seeking volunteers for participation."

Answered by AI
Recent research and studies
~157 spots leftby Mar 2025