Amulet™ 2 Occluder for Atrial Fibrillation

Recruiting at 40 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

475 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to evaluate the safety and effectiveness of Abbott's Amulet™ 2 Left Atrial Appendage (LAA) occluder device (Amulet 2 device) in patients who have non-valvular atrial fibrillation and who are at increased risk for stroke and systemic embolism and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation.

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 data supports the effectiveness of the Amulet™ 2 Left Atrial Appendage Occluder treatment for atrial fibrillation?

Research shows that the Amplatzer Amulet device, which is similar to the Amulet™ 2, is effective in closing the left atrial appendage (a small pouch in the heart) to help prevent strokes in patients with atrial fibrillation (irregular heartbeat). Studies have documented its safety and effectiveness in real-world settings, with positive outcomes observed in both short-term and 12-month follow-ups. ^{1 2 3 4 5}

How is the Amulet™ 2 Occluder treatment different from other treatments for atrial fibrillation?

The Amulet™ 2 Occluder is a device specifically designed to block the left atrial appendage (a small pouch in the heart) to prevent blood clots, which can reduce the risk of stroke in patients with atrial fibrillation. It is an improved version of previous devices, making the implantation process easier and reducing the risk of complications compared to other similar treatments. ^{1 2 5 6 7}

Research Team

Devi Nair, MD

Principal Investigator

Arrhythmia Research Group

Ryan Palmer

Principal Investigator

Abbott Medical

Mohamad Alkhouli, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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 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]

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]

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. Netherlands pubmed.ncbi.nlm.nih.gov

Left atrial appendage occlusion: initial experience with the Amplatzer™ Amulet™. [2016]

2. Slovakia pubmed.ncbi.nlm.nih.gov

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

3. France 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. [2018]

4. Poland pubmed.ncbi.nlm.nih.gov

Twelve-month follow-up of left atrial appendage occlusion with Amplatzer Amulet. [2017]

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

Side-by-Side Comparison of LAA Occlusion Performance With the Amplatzer Cardiac Plug and Amplatzer Amulet. [2019]

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]