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

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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Left Atrial Appendage Occlusion with AMULET using Steerable Delivery Sheaths for Stroke and Atrial Fibrillation?

Research shows that the Amulet device, used for closing the left atrial appendage (a small pouch in the heart), is effective in reducing stroke risk in patients with atrial fibrillation (irregular heartbeat) and is comparable to the Watchman device, another similar treatment. ^{1 2 3 4 5}

Is the Amulet device for left atrial appendage occlusion safe?

The Amulet device has been studied for safety in several trials, including a large randomized trial comparing it to another device, the Watchman. Some studies have reported concerns like device-related blood clots in a small percentage of patients, but overall, it has been evaluated for safety in humans. ^{3 4 5 6 7}

How is the Amulet device with steerable delivery sheaths unique for treating atrial fibrillation?

The Amulet device with steerable delivery sheaths is unique because it allows for left atrial appendage occlusion without the need for general anesthesia and uses a single transseptal puncture, simplifying the procedure compared to traditional methods that may require more invasive techniques. ^{1 2 3 5 8}

Research Team

Dhanunjaya Lakkireddy

Principal Investigator

Kansas City Heart Rhythm Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Left atrial appendage occlusion using LAmbre Amulet and Watchman in atrial fibrillation. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

3-Year Outcomes From the Amplatzer Amulet Left Atrial Appendage Occluder Randomized Controlled Trial (Amulet IDE). [2023]

4. Slovakia pubmed.ncbi.nlm.nih.gov

Retrospective study assessing efficacy and safety of left atrial appendage occlusion. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Left atrial appendage occlusion with the Amplatzer™ Amulet™ device: full results of the prospective global observational study. [2021]

6. Australia pubmed.ncbi.nlm.nih.gov

Device-Related Thrombus After Left Atrial Appendage Occlusion With the Amulet Device. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Rationale and design for AMPLATZER Amulet Left Atrial Appendage Occluder IDE randomized controlled trial (Amulet IDE Trial). [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Intra-cardiac echo for left atrial appendage occlusion. [2018]