Patients with Amulet device using a novel steerable sheath for Stroke

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Research Medical Center, Kansas City, MO
Stroke+1 More
Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath. - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Stroke
  • Atrial Fibrillation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: 6 months

1 day
Number of participants with Acute Closure of Left Atrial Appendage
1 day (procedure day)
Number of device repositions
Number of devices
45 days
Closure Rates
Number of participants with Device related thrombus (DRT)
6 months
Number of participants with Transient ischemic attack (TIA) or cerebrovascular accident (CVA)
7 days
Need for Pericardiocentesis
Number of patients with Cardiac Perforation

Trial Safety

Trial Design

2 Treatment Groups

Patients with Amulet device using a novel steerable sheath
1 of 2
Patients with Amulet device using non-steerable fixed curve sheath
1 of 2
Active Control

300 Total Participants · 2 Treatment Groups

Primary Treatment: Patients with Amulet device using a novel steerable sheath · No Placebo Group · N/A

Patients with Amulet device using a novel steerable sheath
Other
ActiveComparator Group · 1 Intervention: Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath. · Intervention Types: Other
Patients with Amulet device using non-steerable fixed curve sheathNoIntervention Group · 1 Intervention: Patients with Amulet device using non-steerable fixed curve sheath · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Closest Location: Research Medical Center · Kansas City, MO
Photo of kansas city 1Photo of kansas city 2Photo of kansas city 3
2011First Recorded Clinical Trial
5 TrialsResearching Stroke
143 CompletedClinical Trials

Who is running the clinical trial?

Kansas City Heart Rhythm InstituteOTHER
6 Previous Clinical Trials
1,099 Total Patients Enrolled
1 Trials studying Stroke
246 Patients Enrolled for Stroke
Kansas City Heart Rhythm Research FoundationLead Sponsor
14 Previous Clinical Trials
7,524 Total Patients Enrolled
1 Trials studying Stroke
246 Patients Enrolled for Stroke
Dhanunjaya LakkireddyPrincipal InvestigatorKansas City Heart Rhythm Institute
9 Previous Clinical Trials
6,070 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References