Atrial Fibrillation > Amplatzer Amulet LAA Occluder

Left Atrial Appendage Occlusion vs. NOAC for Atrial Fibrillation (CATALYST Trial)

Recruiting in Palo Alto (17 mi)

+130 other locations

Overseen By Vivek Reddy, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Abbott Medical Devices

No Placebo Group

Trial Summary

What is the purpose of this trial?

The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be eligible for long-term NOAC therapy and able to comply with the required medication regimen if you are in the Control Group or after the device implant if you are in the Device Group.

What data supports the effectiveness of the treatment Amplatzer Amulet LAA Occluder for atrial fibrillation?

Research shows that the Amplatzer Amulet device is effective in reducing the risk of stroke in patients with atrial fibrillation by closing off the left atrial appendage, which is a common source of blood clots. Studies comparing it to other devices like the Watchman have assessed its safety and efficacy, indicating it is a viable alternative to oral anticoagulants for some patients.

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Is the Amplatzer Amulet device safe for humans?

The Amplatzer Amulet device, used for left atrial appendage occlusion to prevent strokes in people with atrial fibrillation, has been studied for safety. Research shows it is generally safe, but like any medical procedure, there can be complications.

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How does the Amplatzer Amulet LAA Occluder treatment differ from other treatments for atrial fibrillation?

The Amplatzer Amulet LAA Occluder is a device used to physically block the left atrial appendage in the heart to prevent blood clots and reduce stroke risk in patients with atrial fibrillation, offering an alternative to taking blood-thinning medications like NOACs (non-vitamin K oral anticoagulants). This approach is unique because it provides a non-drug option for patients who may not tolerate or prefer not to use long-term medication.

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Eligibility Criteria

This trial is for adults with non-valvular atrial fibrillation at high risk of stroke (CHA2DS2-VASc score ≥ 3) who can take long-term NOAC therapy. Participants must be able to follow the medication regimen, attend follow-up visits, and provide informed consent. Exclusions include mechanical heart valves, active infections, recent strokes or surgeries, severe renal failure, life expectancy under 2 years, and certain allergies.

Inclusion Criteria

I am at high risk for stroke, with a CHA2DS2-VASc score of 3 or more.

I have a type of irregular heartbeat not caused by a heart valve issue, confirmed by a heart rhythm test.

I am at least 18 years old or at the age of legal consent.

I am eligible for long-term blood thinner medication.

I can follow the NOAC medication plan if placed in the Control Group.

Exclusion Criteria

I have had blood clots in my veins without a known cause, more than once.

I am allergic to or cannot take aspirin, clopidogrel, or blood thinners.

My kidney function is very low but I am not on dialysis.

I have the most severe form of heart failure.

I have been diagnosed with brain artery disease or small vessel disease.

My left atrial appendage has been closed or tied off surgically.

I have been prescribed a P2Y12 inhibitor for over a year.

I have a history of heart valve disease.

I have had surgery or a device placed for an atrial septal defect.

I need long-term blood thinners for a condition that is not atrial fibrillation.

I have an active heart infection or another infection in my blood.

I have low platelet count or need transfusions due to low hemoglobin.

Participant Groups

The study compares the Amulet LAA occlusion device's safety and effectiveness against Non-Vitamin K Oral Antagonists (NOACs) in preventing stroke in patients with atrial fibrillation. It's a randomized control trial where participants are equally divided into two groups: one receiving the Amulet device and the other NOACs chosen by physicians.

Group I: Device Group Experimental Treatment 1 Intervention

Randomized to Amplatzer Amulet LAA occluder

Group II: Control Group Active Control 1 Intervention

Randomized to NOAC

Amplatzer Amulet LAA Occluder is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Amplatzer Amulet LAA Occluder for:

• Reduction of stroke risk in patients with non-valvular atrial fibrillation

🇪🇺 Approved in European Union as Amplatzer Amulet LAA Occluder for:

• Prevention of thromboembolic complications associated with non-valvular atrial fibrillation

Find A Clinic Near You

Research locations nearby Select from list below to view details:

Heart Rhythm Associates Shenandoah, TX

University of Pittsburgh Medical Center Pittsburgh, PA

Jackson Heart Clinic Jackson, MS

Northside Hospital Atlanta, GA

More Trial Locations

Who is running the clinical trial?

Abbott Medical Devices Lead Sponsor

References

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

Safety and efficacy of the Amplatzer Amulet and Watchman 2.5 for left atrial appendage occlusion: A systematic review and meta-analysis. [2022] Left atrial appendage occlusion (LAAO) is an alternative to oral anticoagulation (OAC) to decrease the risk of stroke in patients with nonvalvular atrial fibrillation (NVAF); however, certain complications remain a concern. Amplatzer Amulet and Watchman are the two most popular used devices for preventing stroke in patients with NVAF. We assessed the safety and efficacy of LAAO using the Amplatzer Amulet and Watchman.

2. 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.

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

Outcomes of the roll-in cohort of the Amulet IDE trial of left atrial appendage occlusion. [2022] Left atrial appendage (LAA) occlusion is an alternative therapy to oral anticoagulants to reduce stroke risk in patients with nonvalvular atrial fibrillation (NVAF). The Amulet IDE trial compared the Amplatzer™ Amulet™ occluder (Abbott) with the Watchman™ 2.5 device (Boston Scientific) for LAA occlusion in patients with NVAF.

4. Germany pubmed.ncbi.nlm.nih.gov

Outcomes of left atrial appendage occlusion vs. non-vitamin K antagonist oral anticoagulants in atrial fibrillation. [2022] The effects of left atrial appendage (LAA) occlusion compared to non-vitamin K antagonist oral anticoagulant (NOAC) therapy in patients with atrial fibrillation (AF) remain unknown.

5. Netherlands pubmed.ncbi.nlm.nih.gov

Left atrial appendage closure: Six reasons why I wouldn't choose a percutaneous closure for my appendage. [2018] Left atrial appendage has been shown as a primary source of thrombi in patients with non-valvular atrial fibrillation (AF). Non vitamin k oral anticoagulants (NOAC) have been shown to be safe and effective in the prevention of embolic complications. Current guidelines on AF state that percutaneous left atrial appendage closure (LAAC) might be considered in patients with contraindication to long term oral anticoagulant therapy (OAC). An overview of the main trials on NOAC and LAAC is provided.

6. 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.

7. 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.

8. France pubmed.ncbi.nlm.nih.gov

Left atrial appendage closure versus medical therapy in patients with atrial fibrillation: the APPLY study. [2020] Left atrial appendage closure (LAAC) with AMPLATZER occluders is used for stroke prevention in atrial fibrillation (AF). Net clinical benefit compared to medical therapy has not been tested. The aim of this study was to test whether long-term clinical outcome after LAAC with AMPLATZER occluders may be similar to medical therapy.

9. Netherlands pubmed.ncbi.nlm.nih.gov

Left atrial appendage occlusion using LAmbre Amulet and Watchman in atrial fibrillation. [2020] Left atrial appendage closure (LAAC) has been suggested as an alternative to anticoagulation in non-valvular atrial fibrillation (AF). The present study aimed to compare a LAmbre LAA occluder system [Lifetech Scientific (Shenzhen) Co. Ltd., Shenzhen, China] with the most investigated Amulet (St. Jude Medical Inc., St. Paul, MN, USA) and Watchman (Boston Scientific, Plymouth, MN, USA) devices in terms of peri-procedural and short-term outcomes.