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Device

Amulet™ 2 Occluder for Atrial Fibrillation

N/A

Recruiting

Led By Mohamad Alkhouli, 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

Paroxysmal, persistent, permanent, or long-term/longstanding persistent non-valvular AF and has not been diagnosed with rheumatic mitral valve disease

CHA2DS2-VASc score of ≥2 for males or ≥3 for females

Must not have

New York Heart Association (NYHA) Class IV Congestive Heart Failure

Subject anatomy will not accommodate or is contraindicated for transesophageal echocardiography probe use (e.g., presence of esophageal varices, esophageal stricture, or history of esophageal cancer), or subject has experienced adverse events related to transesophageal echocardiography acquisition or has refused transesophageal echocardiography acquisition in the past

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test how safe and effective Abbott's Amulet™ 2 Left Atrial Appendage (LAA) occluder device is for patients with atrial fibrillation who are at

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed, similar devices may cause complications like bleeding, heart tissue damage, or device-related issues such as improper placement or movement after implantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a type of irregular heartbeat not caused by a heart valve issue.

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My stroke risk score is 2 or more if I'm male, or 3 or more if I'm female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe heart failure.

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I cannot have or have had issues with a specific heart ultrasound due to my throat condition or past bad experiences.

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I have had a procedure to close or block my heart's left atrial appendage.

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I have an active infection in my heart or bloodstream.

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I have severe kidney problems or am on long-term dialysis.

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I haven't had any surgery or procedure requiring anesthesia in the last 30 days.

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I had a procedure to correct heart rhythm issues within the last 60 days.

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I am not planning any surgery that requires anesthesia within 60 days after the Amulet 2 device implant, except for study-related activities.

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I have low platelet counts or need transfusions for low hemoglobin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The primary effectiveness endpoint is LAA occlusion defined as no peri-device flow or peri-device flow ≤5mm based on TEE/TOE at the 45-day follow-up visit.

The primary safety endpoint is the occurrence of any prespecified safety events through 7 days post-procedure or hospital discharge, whichever is later.

Secondary study objectives

The secondary effectiveness endpoint is the composite of ischemic stroke or systemic embolism at 24 months.