Left Atrial Appendage Occlusion vs. NOAC for Atrial Fibrillation (CATALYST Trial)
Palo Alto (17 mi)Overseen byVivek Reddy, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
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.
Is the Amplatzer Amulet LAA Occluder treatment a promising option for atrial fibrillation?Yes, the Amplatzer Amulet LAA Occluder is a promising treatment for atrial fibrillation. It is an alternative to blood-thinning drugs and helps reduce the risk of stroke in patients with this heart condition.34789
What safety data exists for LAAO with Amplatzer Amulet and NOACs for atrial fibrillation?Several studies have evaluated the safety of the Amplatzer Amulet device for left atrial appendage occlusion (LAAO). These include a global observational study assessing its safety and efficacy, a systematic review and meta-analysis comparing it with the Watchman device, and a retrospective study in Slovakia focusing on procedural efficacy and safety. Additionally, a study compared the Amplatzer Amulet with the Amplatzer Cardiac Plug, highlighting improvements in implantation and reduced complications. These studies collectively provide safety data for the Amplatzer Amulet in LAAO.14568
What data supports the idea that Left Atrial Appendage Occlusion vs. NOAC for Atrial Fibrillation is an effective treatment?The available research shows that Left Atrial Appendage Occlusion (LAAO) is an alternative treatment to oral anticoagulants, like NOACs, for reducing the risk of stroke in patients with atrial fibrillation. Studies have compared devices like the Amplatzer Amulet and Watchman for LAAO, indicating they are popular choices for this purpose. However, the research also notes that the effects of LAAO compared to NOACs are not fully known, suggesting that both treatments have their own benefits and limitations. Additionally, LAAO might be considered for patients who cannot take long-term oral anticoagulants, according to current guidelines.24789
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you must stop taking your current medications. However, if you are in the Control Group, you must be able to comply with the NOAC medication regimen. If you are in the Device Group, you must comply with the post-device implant medication regimen. If you require long-term OAC therapy for a condition other than AF, you cannot participate in the trial.
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.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Device GroupExperimental Treatment1 Intervention
Randomized to Amplatzer Amulet LAA occluder
Group II: Control GroupActive Control1 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 nearbySelect from list below to view details:
Heart Rhythm AssociatesShenandoah, TX
University of Pittsburgh Medical CenterPittsburgh, PA
Jackson Heart ClinicJackson, MS
Northside HospitalAtlanta, GA
More Trial Locations
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Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
References
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.
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.
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.
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.
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.
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.
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.
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.
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.