Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
458 participants
INTERVENTIONAL
2024-11-11
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Amulet™ 2 Left Atrial Appendage (LAA) Occluder
Transcatheter left atrial appendage (LAA) occluder
Amulet™ 2 Left Atrial Appendage (LAA) Occluder
Patient will undergo the implantation of the Amulet™ 2 Left Atrial Appendage (LAA) Occluder
Interventions
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Amulet™ 2 Left Atrial Appendage (LAA) Occluder
Patient will undergo the implantation of the Amulet™ 2 Left Atrial Appendage (LAA) Occluder
Eligibility Criteria
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Inclusion Criteria
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
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.
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
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Ryan Palmer
Role: STUDY_DIRECTOR
Abbott Medical
Devi Nair, MD
Role: PRINCIPAL_INVESTIGATOR
Arrhythmia Research Group
Mohamad Alkhouli, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Arizona Arrhythmia Research Group
Phoenix, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Baptist Medical Center
Jacksonville, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas, United States
Henry Ford Providence Southfield Hospital
Southfield, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
CHI Health Creighton University Medical Center-Bergan Mercy
Omaha, Nebraska, United States
NYU Langone Health
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Roper Hospital
Charleston, South Carolina, United States
Trident Medical Center
Charleston, South Carolina, United States
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia
Austin, Texas, United States
Baylor Scott & White All Saints Medical Center
Fort Worth, Texas, United States
Vital Heart and Vein
Humble, Texas, United States
Baylor Scott & White - The Heart Hospital Plano
Plano, Texas, United States
Heart Rhythm Associates
Shenandoah, Texas, United States
Hôpital Civil Marie Curie
Lodelinsart, , Belgium
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, Canada
Aarhus Universitetshospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
CHU Gabriel Montpied
Clermont-Ferrand, Auvergn, France
Institute Cardio. Paris-Sud - Institut Jacques Cartier
Massy, , France
Cardioangiologisches Centrum am Bethanien Krankenhaus
Frankfurt am Main, Hesse, Germany
Deutsches Herzzentrum der Charité
Berlin, , Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, , Germany
Heinrich-Braun-Klinikum gemeinnützige gGmbH Standort Zwickau
Zwickau, , Germany
Ospedale San Raffaele
Milan, , Italy
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Center Inselspital Bern
Bern, Canton of Bern, Switzerland
Countries
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Other Identifiers
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G240218
Identifier Type: OTHER
Identifier Source: secondary_id
ABT-CIP-10523
Identifier Type: -
Identifier Source: org_study_id