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New heart implant aims to cut stroke risk without blood thinners

NCT ID NCT06707688

Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study tests a device called Amulet 2 that is implanted in the heart to seal off a small pouch (the left atrial appendage) where blood clots can form in people with atrial fibrillation. The goal is to reduce the risk of stroke without needing long-term blood thinners. About 458 participants with AF and a high stroke risk are being followed for safety and effectiveness over 24 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

458 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular AF and has not been diagnosed with rheumatic mitral valve disease 2. CHA2DS2-VASc score of ≥2 for males or ≥3 for females 3. Has an appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation 4. Subject is eligible to stop anticoagulation if the LAA is sealed based on the implanting physician's opinion 5. Subject is able to comply with the protocol defined pharmacologic regimen following Amulet 2 device implant (as described in Section 6.5) 6. Subject is able to understand and willing to provide written informed consent to participate in the clinical investigation 7. Subject is able and willing to return for required follow-up visits and protocol required clinical investigation activities 8. 18 years of age or older, or the age of legal consent Exclusion Criteria: 1. Required to take P2Y12 platelet inhibitor beyond 6 months when Amulet 2 LAA Occluder implant procedure would occur 2. Is considered at high risk for general anesthesia in the opinion of the Investigator or based on past adverse reaction(s) requiring medical intervention or which resulted in prolongation of hospital stay 3. Atrial septal defect or patent foramen ovale repair or occluder 4. Implanted with a mechanical valve prosthesis 5. 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 6. Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to when Amulet 2 device implant procedure would occur (any intervention or surgery that utilized anesthesia, anesthetic, or sedation) 7. Underwent catheter ablation for AF or atrial flutter within 60 days prior to when Amulet 2 device implant procedure would occur 8. Inpatient hospitalization due to clinical event or other sequelae within the past 7 days (i.e., not related to planned clinical study procedure or assessments) 9. Subject is planning any cardiac or non-cardiac intervention or surgery within 60 days after when Amulet 2 device implant procedure would occur (any intervention or surgery that utilized anesthesia, anesthetic, or sedation), except for study related activities 10. Inferior vena cava filter present 11. Left ventricular ejection fraction ≤30% (per most recent assessment) 12. Experienced stroke or transient ischemic attack within 90 days prior to when Amulet 2 device implant procedure would occur 13. Experienced myocardial infarction (with or without intervention) within 90 days prior to when Amulet 2 device implant procedure would occur 14. New York Heart Association (NYHA) Class IV Congestive Heart Failure 15. Known symptomatic carotid disease (defined as \> 50% lumen diameter narrowing on CTA, MRA, or TCD with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is \< 50% lumen diameter narrowing 16. Underwent prior attempted endocardial, epicardial, or surgical LAA closure or occlusion, defined as deployment of a device or surgical procedure whether successful or unsuccessful 17. Reversible cause of AF (i.e., secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures) 18. History of idiopathic or recurrent venous thromboembolism within the past 5 years 19. Thrombocytopenia (defined as \< 50,000 platelets per microliter (\<50 x 109/L) or anemia (defined as hemoglobin \< 10 g/dL) requiring transfusions 20. Known hypersensitivity to any portion of the device material or individual components of the Amulet 2 device (e.g., nickel allergy) 21. Actively enrolled in, or plans to enroll in, a concurrent clinical investigation in which the active treatment arm may confound the results of the VERITAS Study. Each instance must be brought to the attention of the Sponsor to determine eligibility. 22. Is pregnant or breastfeeding, or pregnancy is planned during the course of the investigation 23. Active endocarditis or other infection producing bacteremia 24. Transient case of AF (i.e., never previously detected, provoked/induced by surgical or catheter manipulations, etc.) 25. Severe renal failure (estimated glomerular filtration rate \<30 ml/min/1.73m2) or on chronic dialysis 26. Life expectancy is less than 2 years in the opinion of the Investigator 27. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the Investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow up requirements, or impact the scientific soundness of the clinical investigation results. Anatomical Exclusion Criteria: 1. Intracardiac thrombus 2. Existing circumferential pericardial effusion \>2 mm 3. Mitral valve stenosis, defined as a mitral valve area of \<1.5 cm2 4. Inter-atrial communication (PFO/ASD with right to left shunt, if TEE performed) with an atrial septal aneurysm (excursion \>15 mm or length ≥15 mm; excursion defined as maximal protrusion of the atrial septal aneurysm beyond the plane of the atrial septum) or large shunt (i.e., during Valsalva maneuver ≥20 bubbles of right-to-left shunt within 3 cardiac cycles after contrast media enters the right atrium, if TEE performed) 5. Complex atheroma of the descending aorta and/or aortic arch, defined as plaque \>4 mm in thickness, plaque ulceration, and/or mobile lesions 6. Cardiac tumor 7. LAA anatomy that cannot accommodate the Amulet 2 device, as per manufacturer's IFU (i.e., the LAA size must be within the sizing chart of the Amulet 2 device) 8. Placement of the device would damage or interfere with the function of any intracardiac or intravascular structure

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Conditions

The condition(s) this trial relates to.

atrial fibrillation stroke disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation (AF) STOKE

Contacts and locations

Locations

  • Aarhus Universitetshospital

    Aarhus, Denmark

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Arizona Arrhythmia Research Group

    Phoenix, Arizona, 85016, United States

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401, United States

  • Baptist Medical Center

    Jacksonville, Florida, 32207, United States

  • Baylor Scott & White - The Heart Hospital Plano

    Plano, Texas, 75093, United States

  • Baylor Scott & White All Saints Medical Center

    Fort Worth, Texas, 76104, United States

  • CHI Health Creighton University Medical Center-Bergan Mercy

    Omaha, Nebraska, 68124, United States

  • CHU Gabriel Montpied

    Clermont-Ferrand, Auvergn, France

  • Cardioangiologisches Centrum am Bethanien Krankenhaus

    Frankfurt am Main, Hesse, Germany

  • Center Inselspital Bern

    Bern, Canton of Bern, Switzerland

  • Deutsches Herzzentrum der Charité

    Berlin, Germany

  • Heart Rhythm Associates

    Shenandoah, Texas, 77380, United States

  • Heinrich-Braun-Klinikum gemeinnützige gGmbH Standort Zwickau

    Zwickau, Germany

  • Henry Ford Providence Southfield Hospital

    Southfield, Michigan, 48075, United States

  • Hospital Clinico San Carlos

    Madrid, Spain

  • Hospital Clínic de Barcelona

    Barcelona, Spain

  • Hospital Universitario de Salamanca

    Salamanca, Spain

  • Hôpital Civil Marie Curie

    Lodelinsart, Belgium

  • Institut de Cardiologie de Montreal (Montreal Heart Inst.)

    Montreal, Quebec, Canada

  • Institute Cardio. Paris-Sud - Institut Jacques Cartier

    Massy, France

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park, Kansas, 66211, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mount Sinai Hospital

    New York, New York, 10019, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Northside Hospital

    Atlanta, Georgia, 30342, United States

  • Ospedale San Raffaele

    Milan, Italy

  • Rigshospitalet

    Copenhagen, Denmark

  • Roper Hospital

    Charleston, South Carolina, 29401, United States

  • Texas Cardiac Arrhythmia

    Austin, Texas, 78705, United States

  • Trident Medical Center

    Charleston, South Carolina, 29406, United States

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K18 4W7, Canada

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    Lübeck, Germany

  • Vanderbilt Heart & Vascular Institute

    Nashville, Tennessee, 37232, United States

  • Vital Heart and Vein

    Humble, Texas, 77338, United States

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