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Device

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

N/A
Recruiting
Led By Vivek Reddy, MD
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At high risk of stroke or systemic embolism, defined as a CHA2DS2-VASc score of ≥ 3
Documented paroxysmal, persistent, or permanent non-valvular AF (documentation must include an electrocardiogram, Holter, or event recorder)
Must not have
History of idiopathic or recurrent venous thromboembolism
Known contraindication to, or allergic to, aspirin, clopidogrel, or OAC medication use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at whether the Amulet LAA occluder is safe and effective compared to NOAC therapy in patients with non-valvular AF who are at increased risk for ischemic stroke and who have been recommended for long-term NOAC therapy.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include complications from catheterization procedures for those receiving the Amulet device such as bleeding or infection risks. For NOACs group side effects might involve bleeding issues or allergic reactions to medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at high risk for stroke, with a CHA2DS2-VASc score of 3 or more.
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I have a type of irregular heartbeat not caused by a heart valve issue, confirmed by a heart rhythm test.
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I am at least 18 years old or at the age of legal consent.
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I am eligible for long-term blood thinner medication.
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I can follow the NOAC medication plan if placed in the Control Group.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had blood clots in my veins without a known cause, more than once.
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I am allergic to or cannot take aspirin, clopidogrel, or blood thinners.
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My kidney function is very low but I am not on dialysis.
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I have the most severe form of heart failure.
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I have been diagnosed with brain artery disease or small vessel disease.
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My left atrial appendage has been closed or tied off surgically.
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I have been prescribed a P2Y12 inhibitor for over a year.
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I have a history of heart valve disease.
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I have had surgery or a device placed for an atrial septal defect.
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I need long-term blood thinners for a condition that is not atrial fibrillation.
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I have an active heart infection or another infection in my blood.
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I have low platelet count or need transfusions due to low hemoglobin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite of ischemic stroke or systemic embolism
Composite of ischemic stroke, systemic embolism, or cardiovascular (CV) mortality
Major bleeding or clinically relevant non-major bleeding (CRNMB) events, excluding procedure related events
Secondary study objectives
Disabling or fatal strokes
Major bleeding or CRNMB events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
650 Previous Clinical Trials
408,693 Total Patients Enrolled
76 Trials studying Atrial Fibrillation
29,390 Patients Enrolled for Atrial Fibrillation
Vivek Reddy, MDPrincipal InvestigatorMt. Sinai Medical Center
34 Previous Clinical Trials
10,494 Total Patients Enrolled
19 Trials studying Atrial Fibrillation
5,060 Patients Enrolled for Atrial Fibrillation

Media Library

Amplatzer Amulet LAA Occluder (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04226547 — N/A
Atrial Fibrillation Research Study Groups: Device Group, Control Group
Atrial Fibrillation Clinical Trial 2023: Amplatzer Amulet LAA Occluder Highlights & Side Effects. Trial Name: NCT04226547 — N/A
Amplatzer Amulet LAA Occluder (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04226547 — N/A
~1010 spots leftby Aug 2027
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