Amulet™ 2 Occluder for Atrial Fibrillation

Not currently recruiting at 50 trial locations

Overseen By Rodney Horton

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Must not be taking: P2Y12 inhibitors

Disqualifiers: Mechanical valve, Recent stroke, Severe renal failure, NYHA Class IV, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Amulet™ 2 Left Atrial Appendage (LAA) Occluder, designed to help individuals with atrial fibrillation (AF) who are at risk of stroke. The device serves as an alternative to blood thinners and is inserted into the heart to block a small area where dangerous blood clots can form. The study seeks participants diagnosed with non-valvular atrial fibrillation who are interested in a non-drug option to prevent strokes. Those with AF who have been advised to avoid certain medications might find this trial suitable. As an unphased trial, it offers the opportunity to explore a non-drug option that could potentially improve quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that participants should be eligible to stop anticoagulation if the device seals the left atrial appendage. It's best to discuss your specific medications with the trial team.

What prior data suggests that the Amulet™ 2 device is safe for patients with atrial fibrillation?

Research has shown that the Amulet™ 2 Left Atrial Appendage Occluder is generally safe for individuals with atrial fibrillation, a condition that increases stroke risk. In a large study, the Amulet occluder proved safe and effective over the long term. Over five years, it matched the safety of other devices and excelled in sealing the heart's left atrial appendage. Another study found that most patients (over 96%) could stop using blood thinners for three years after receiving the device. This finding suggests it is well-tolerated and can serve as a good alternative to medication for those at high risk of stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Amulet™ 2 Left Atrial Appendage (LAA) Occluder is unique because it offers a minimally invasive approach to reducing stroke risk in people with atrial fibrillation, a condition where irregular heartbeats can lead to blood clots. Unlike traditional methods that often rely on long-term blood thinners like warfarin, the Amulet™ 2 device is implanted via a catheter to physically block the left atrial appendage, where clots commonly form. This method eliminates the need for ongoing medication management and monitoring, potentially minimizing bleeding risks associated with blood thinners. Researchers are excited about this treatment because it provides a promising alternative for patients who cannot tolerate blood thinners or who are looking for a more permanent solution.

What evidence suggests that the Amulet™ 2 device is effective for atrial fibrillation?

Research shows that the Amulet™ 2 Left Atrial Appendage Occluder, which participants in this trial will receive, works well for people with atrial fibrillation, a condition that can cause irregular heartbeats. Studies have found that over 96% of patients could stop taking blood thinners after three years, benefiting those who prefer not to rely on medication. The device completely closes off the left atrial appendage, reducing stroke risk in people with atrial fibrillation. Compared to earlier versions, the Amulet 2 seals this area more effectively, providing better coverage of the left atrial appendage. Overall, it offers a promising option for those at risk of stroke due to atrial fibrillation who want to avoid drugs. ^{2 3 5 6 7}

Who Is on the Research Team?

Devi Nair, MD

Principal Investigator

Arrhythmia Research Group

Ryan Palmer

Principal Investigator

Abbott Medical

Mohamad Alkhouli, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients with non-valvular atrial fibrillation at increased risk of stroke who need a non-drug alternative to oral anticoagulants. Specific eligibility details are not provided, but typically include certain health requirements and no contraindications for the device.

Inclusion Criteria

Subject is able to comply with the protocol defined pharmacologic regimen following Amulet 2 device implant (as described in Section 6.5)

Subject is able to understand and willing to provide written informed consent to participate in the clinical investigation

I can and will attend all required follow-up visits.

Exclusion Criteria

Known hypersensitivity to any portion of the device material or individual components of the Amulet 2 device (e.g., nickel allergy)

Inferior vena cava filter present

Left ventricular ejection fraction ≤30% (per most recent assessment)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Amulet™ 2 Left Atrial Appendage (LAA) occluder device via transcatheter procedure

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 45-day follow-up visit for TEE/TOE assessment

45 days

1 visit (in-person)

Long-term Follow-up

Participants are monitored for ischemic stroke or systemic embolism over a 24-month period

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Amulet™ 2 Left Atrial Appendage (LAA) Occluder

Trial Overview The VERITAS Study by Abbott Medical is testing the safety and effectiveness of the Amulet™ 2 LAA Occluder device in preventing strokes in atrial fibrillation patients who can't take blood thinners.

How Is the Trial Designed?

Group I: Amulet™ 2 Left Atrial Appendage (LAA) Occluder Experimental Treatment 1 Intervention

Transcatheter left atrial appendage (LAA) occluder

Amulet™ 2 Left Atrial Appendage (LAA) Occluder is already approved in United States, European Union for the following indications:

Approved in United States as Amplatzer Amulet for:

• Non-valvular atrial fibrillation for stroke prevention

Approved in European Union as Amplatzer Amulet for:

• Non-valvular atrial fibrillation for stroke prevention

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Published Research Related to This Trial

The Amplatzer Amulet device demonstrated a high procedural success rate of 98% in occluding the left atrial appendage (LAA) for stroke prevention in patients with atrial fibrillation, based on a study of 50 patients followed for 12 months.

While there were some complications, including 8% experiencing major adverse events, follow-up imaging showed complete sealing of the LAA in all patients assessed, indicating the device's efficacy in preventing potential stroke risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twelve-month follow-up of left atrial appendage occlusion with Amplatzer Amulet. Kleinecke, C., Park, JW., Gödde, M., et al.[2017]

In a study of 59 patients undergoing left atrial appendage occlusion (LAAO), the Amplatzer Amulet device demonstrated a significant reduction in residual leaks compared to the Amplatzer Cardiac Plug (ACP), with only 8% of Amulet patients experiencing leaks versus 48% of ACP patients.

Both devices had similar procedural success rates and short-term outcomes, with no major complications like embolization or stroke, indicating that the Amulet is a safe and effective option for LAAO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side-by-Side Comparison of LAA Occlusion Performance With the Amplatzer Cardiac Plug and Amplatzer Amulet. Abualsaud, A., Freixa, X., Tzikas, A., et al.[2019]

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 1,088 patients with non-valvular atrial fibrillation, the AMPLATZER Amulet device achieved a high implantation success rate of 99% and a low major adverse event rate of 3.2% during the procedure.

Follow-up transoesophageal echocardiography showed that 98.2% of patients had adequate closure of the left atrial appendage, indicating effective treatment, with only a 1.5% rate of device-associated thrombus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left atrial appendage occlusion with the AMPLATZER Amulet device: periprocedural and early clinical/echocardiographic data from a global prospective observational study. Landmesser, U., Schmidt, B., Nielsen-Kudsk, JE., et al.[2018]

In a study of 25 patients undergoing percutaneous left atrial appendage (LAA) occlusion, the Amplatzer Amulet device was successfully implanted in 96% of cases, demonstrating high feasibility and safety with no procedural strokes or major complications.

Follow-up assessments showed complete sealing of the LAA in all patients, with only one case of device thrombosis that did not result in any clinical issues, indicating strong short-term efficacy of the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left atrial appendage occlusion: initial experience with the Amplatzer™ Amulet™. Freixa, X., Abualsaud, A., Chan, J., et al.[2016]

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 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.jcin.2023.06.022

3-Year Outcomes From the Amplatzer Amulet Left Atrial ... The Amulet occluder demonstrated continued safety and effectiveness with over 96% free of oral anticoagulation usage through 3 years in a high-risk population.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0735109724103130

5-Year Results From the AMPLATZER Amulet Left Atrial ... The dual-seal Amulet LAA occluder demonstrated noninferior safety and effectiveness with superior LAA occlusion rates compared with the first-generation ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02879448

NCT02879448 | AMPLATZER™ Amulet™ LAA Occluder Trial The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left ...

4. 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.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37587599/

3-Year Outcomes From the Amplatzer Amulet Left Atrial ... The Amulet occluder demonstrated continued safety and effectiveness with over 96% free of oral anticoagulation usage through 3 years in a high-risk population.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39570242/?dopt=Abstract

5-Year Results From the AMPLATZER Amulet Left Atrial ... The 5-year outcomes from the largest randomized LAAO clinical trial demonstrated the long-term safety and effectiveness of the Amulet occluder and Watchman 2.5 ...

7. ahajournals.org ahajournals.org/doi/10.1161/circ.152.suppl_3.4371051

Abstract 4371051: Comparative Effectiveness and Safety of ... Results: We analyzed 27 studies (12 RCTs, 15 observational; 65,308 patients). Procedural success exceeded 97% across devices. Annual ischemic ...