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

Not yet recruiting at 6 trial locations

Overseen By Donita Atkins

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kansas City Heart Rhythm Research Foundation

Disqualifiers: Pregnancy, Prisoners, Unwillingness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new steerable delivery tool outperforms the traditional fixed tool for a heart procedure called left atrial appendage occlusion (LAAO). LAAO reduces stroke risk in individuals with atrial fibrillation, a condition characterized by an irregular heartbeat. The trial will compare two groups: one using the traditional fixed tool and the other using the new steerable tool. Individuals with atrial fibrillation scheduled to receive an Amplatzer Amulet device (a dual mechanism closure device) might be suitable candidates. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future heart procedures.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the novel steerable sheath is safe for left atrial appendage occlusion?

Research has shown that using a new flexible tool with the Amulet device for closing a part of the heart is generally safe. One study found that this tool is easy to use and does not increase complications during the procedure, allowing patients to have a smooth experience without additional issues.

However, another study reported 59 problems, with 58 related to the tool. While this might seem concerning, these findings contribute to ensuring the treatment's safety.

Overall, the flexible tool functions effectively in closing the heart area, which is crucial for preventing strokes in individuals with an irregular heartbeat. Evidence suggests that the treatment is generally well-tolerated, though, like any medical procedure, some risks are involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the Amulet device with a novel steerable sheath for left atrial appendage occlusion because it could offer more precise placement compared to the standard fixed curve sheath. This precision might lead to better outcomes in preventing strokes for patients with atrial fibrillation. The steerable sheath allows doctors more control during the procedure, potentially reducing complications and improving the overall success rate of the treatment.

What evidence suggests that this trial's treatments could be effective for stroke and atrial fibrillation?

Research has shown that the Amulet device can reduce stroke risk in patients with atrial fibrillation by blocking a part of the heart where clots often form. Studies have found that these devices lower the chance of stroke compared to not using blood thinners. In this trial, some participants will receive the Amulet device with a novel steerable sheath, which allows doctors to position it more accurately and may lead to better results. A small study found that this flexible tube is especially helpful for patients with larger heart chambers. Meanwhile, other participants will receive the Amulet device using a non-steerable fixed curve sheath. Overall, the Amulet device, especially with the flexible tube, appears to make the procedure safer and more effective. ^{2 4 6 7 8}

Who Is on the Research Team?

Dhanunjaya Lakkireddy

Principal Investigator

Kansas City Heart Rhythm Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have atrial fibrillation and are having a specific heart device implanted.

Exclusion Criteria

Prisoners

Pregnant or breastfeeding patients

Patients not willing to participate in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo left atrial appendage occlusion with the Amulet device using either a non-steerable fixed curve sheath or a novel steerable sheath

1 day

1 visit (in-person)

Initial Follow-up

Participants are monitored for cardiac perforation and need for pericardiocentesis

7 days

Extended Follow-up

Participants are monitored for closure rates and device-related thrombus

45 days

Long-term Follow-up

Participants are monitored for transient ischemic attack or cerebrovascular accident

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath

Trial Overview 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.

How Is the Trial Designed?

Group I: Patients with Amulet device using non-steerable fixed curve sheath Active Control 1 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 sheath Active Control 1 Intervention

Patients undergoing left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.

Who Is Running the Clinical Trial?

Kansas City Heart Rhythm Research Foundation

Lead Sponsor

Trials

30

Recruited

14,000+

Kansas City Heart Rhythm Institute

Collaborator

Trials

9

Recruited

1,700+

Published Research Related to This Trial

In a study of 30 patients with atrial fibrillation at high risk of stroke, the Amplatzer Amulet device successfully closed the left atrial appendage in 96.7% of cases, demonstrating its efficacy as a treatment alternative to anticoagulation therapy.

The procedure was found to be safe, with no reported complications, and it allows for a shift from anticoagulants to antiplatelet medications like acetylsalicylic acid and clopidogrel post-procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective study assessing efficacy and safety of left atrial appendage occlusion. Misikova, S., Haramiova, Z., Juhas, S., et al.[2020]

The Amulet IDE Trial is a large, ongoing study involving 1878 patients with non-valvular atrial fibrillation, comparing the safety and effectiveness of the AMPLATZER Amulet device to the WATCHMAN device for stroke prevention over a 5-year period.

The trial aims to assess key outcomes such as procedure-related complications, major bleeding, and the effectiveness of the devices in preventing ischemic strokes, making it a significant investigation into left atrial appendage occlusion (LAAO) techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design for AMPLATZER Amulet Left Atrial Appendage Occluder IDE randomized controlled trial (Amulet IDE Trial). Lakkireddy, D., Windecker, S., Thaler, D., et al.[2020]

In a study of 140 patients with non-valvular atrial fibrillation, the LAmbre LAA occluder system demonstrated a 100% implant success rate, comparable to the Amulet and Watchman devices, indicating its effectiveness as an alternative to anticoagulation.

All three devices (LAmbre, Amulet, and Watchman) showed low rates of major peri-procedural adverse events and maintained good clinical outcomes at six months, suggesting they are safe options for left atrial appendage closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left atrial appendage occlusion using LAmbre Amulet and Watchman in atrial fibrillation. Chen, S., Chun, KRJ., Bordignon, S., et al.[2020]

In a study of 1088 patients with atrial fibrillation, left atrial appendage occlusion (LAAO) using the Amplatzer Amulet device achieved a 99.1% implant success rate and significantly reduced the ischaemic stroke rate by 67% compared to predicted risks.

The procedure demonstrated a low incidence of major adverse events (4.0% within 7 days), with only 1.6% of patients developing device-related thrombus, indicating a favorable safety profile for the Amulet device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left atrial appendage occlusion with the Amplatzer™ Amulet™ device: full results of the prospective global observational study. Hildick-Smith, D., Landmesser, U., Camm, AJ., et al.[2021]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jacadv.2022.100136

Left Atrial Appendage Occlusion: Current Advances and ... In this article, we provide a contemporary overview of left atrial appendage occlusion focusing on 4 key remaining challenges: efficacy data, peri-device leak, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11307776/

Steerable Delivery Sheath for Left Atrial Appendage Closure ... The main results of this pilot study are as follows: (1) severe LA enlargement was a frequent finding in patients referred for LAAC; (2) the use of an SDS ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05464511?tab=history&a=5

Record History | ver. 5: 2025-08-27 | NCT05464511 In this study investigators aim to compare the outcome of patients undergoing left atrial appendage occlusion with the dual mechanism closure Amulet device ...

4. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)02508-1/fulltext

2025 SCAI/HRS clinical practice guidelines on ... Left atrial appendage occlusion (LAAO) devices reduce the risk of atrial fibrillation-associated stroke relative to no oral anticoagulation.

5. sciencedirect.com sciencedirect.com/science/article/pii/S247487062400109X

Left Atrial Appendage Occlusion: Expanding Indications ... Left atrial appendage occlusion (LAAO) is safe and effective in reducing stroke patients with atrial fibrillation. •. New devices and techniques have ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37679961/

Adverse events associated with amplatzer left atrial ... Results: A total of 59 adverse events were reported, of which 58 were sheath-related events, and one was a wire-related event. The most commonly ...

7. structuralheart.abbott structuralheart.abbott/products/laa-closure-device/amplatzer-amulet-laa-occluder

Amplatzer Amulet LAA Occluder | Left Atrial Appendage ... The Amulet LAA Occluder offers complete closure of the left atrial appendage (LAA) for patients with atrial fibrillation (AF) at risk of ischemic stroke.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772930323015156

Steerable Delivery Sheath for Left Atrial Appendage ... The use of SDS appears feasible and safe, leading to more efficient closures on follow-up imaging without a higher risk of periprocedural complications.