Amulet™ 2 Occluder for Atrial Fibrillation

Recruiting in Palo Alto (17 mi)

+40 other locations

Overseen by Mohamad Alkhouli, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Approved in 2 Jurisdictions

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.

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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.

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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

I am 18 years old or older.

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

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)

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Baptist Medical Center Jacksonville, FL

Providence Hospital Southfield, MI

Kansas City Cardiac Arrhythmia Research Foundation Overland Park, KS

Vital Heart and Vein Humble, TX

More Trial Locations

Who Is Running the Clinical Trial?

Abbott Medical Devices Lead Sponsor

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Left atrial appendage occlusion: initial experience with the Amplatzer™ Amulet™. [2016] The Amplatzer™ Amulet™ (Amulet) is the evolution of the Amplatzer™ Cardiac Plug, a dedicated device for percutaneous left atrial appendage (LAA) occlusion. The new device has been designed to facilitate the implantation process, improve the sealing performance and further reduce the risk of complications. The objective of the study was to describe the initial experience with the Amplatzer Amulet for percutaneous LAA occlusion.

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

Retrospective study assessing efficacy and safety of left atrial appendage occlusion. [2020] To describe the initial experience with Amplatzer Amulet in left atrial appendage occlusion in Slovakia. To evaluate procedural efficacy and safety.

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] The global, prospective AMPLATZER Amulet observational study documents real-world periprocedural, transoesophageal echocardiographic (TEE) and clinical outcomes from left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device. The aim of this report is to describe the periprocedural and early clinical/TEE results from this study.

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

Twelve-month follow-up of left atrial appendage occlusion with Amplatzer Amulet. [2017] The Amplatzer Amulet (St. Jude Medical, Minneapolis, MN, USA) is a second gen-eration Amplatzer device for left atrial appendage (LAA) occlusion (LAAO) for stroke prophylaxis in patients with atrial fibrillation. This research sought to assess the clinical performance of the Amplatzer Amulet device and in follow up for 12 months.

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] To evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) with the Amplatzer™ Amulet™ occluder.

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] The Amplatzer Amulet, a second-generation device for left atrial appendage occlusion (LAAO), has been designed to facilitate the implantation process, improve the closure performance, and reduce the risk of complications. The objective of this study was to compare the outcomes of the Amplatzer Cardiac Plug (ACP) with the Amplatzer Amulet for LAAO, with a special focus on the incidence of residual leaks.

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] The Amulet IDE Trial is an ongoing, prospective, randomized, multi-national trial, designed to evaluate the safety and effectiveness of the AMPLATZER Amulet Left Atrial Appendage Occluder for stroke prevention in comparison to the WATCHMAN Left Atrial Appendage Closure Device in patients with non-valvular atrial fibrillation. METHODS: Non-valvular atrial fibrillation patients at high risk of stroke (CHADS2 score ≥2 or a CHA2DS2-VASc score of ≥3) who are suitable candidates for left atrial appendage occlusion (LAAO) will be fully informed and requested to participate in the trial. A total of 1878 patients at up to 150 sites worldwide will be randomized in a 1:1 ratio between the AMPLATZER Amulet device (investigational) and the Boston Scientific WATCHMAN device (control). Each patient will be followed for 5 years, with follow-up assessments at discharge, 45 days, 3, 6, 9, 12, 18, and 24 months and then annually. The trial has three primary endpoints: A composite of procedure-related complications, or all-cause death, or major bleeding through 12 months (safety); a composite of ischemic stroke or systemic embolism through 18 months (effectiveness); and effective device LAAO, defined as residual jet around the device ≤5 mm at the 45-day visit (mechanism of action). SUMMARY: The Amulet IDE Trial is the first randomized head-to-head LAAO device trial and will provide data for the AMPLATZER Amulet occluder in a population with a high risk of stroke and bleeding.