Abbott Medical - VERITAS Study

Running, not enrolling · Not applicable

Conditions studied: Atrial Fibrillation (AF), Stoke

In brief

The primary objective of this study is to evaluate the safety and effectiveness of Abbott's Amulet™ 2 Left Atrial Appendage (LAA) occluder device (Amulet 2 device) in patients who have non-valvular atrial fibrillation and who are at increased risk for stroke and systemic embolism and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation.

Key facts

Study ID

NCT06707688

Run by

Abbott Medical Devices

People needed

458

Starts

2024-11-07

Expected to finish

2027-09-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Has an appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation
• Subject is eligible to stop anticoagulation if the LAA is sealed based on the implanting physician's opinion
• Subject is able to comply with the protocol defined pharmacologic regimen following Amulet 2 device implant (as described in Section 6.5)
• Subject is able to understand and willing to provide written informed consent to participate in the clinical investigation
• Subject is able and willing to return for required follow-up visits and protocol required clinical investigation activities
• 18 years of age or older, or the age of legal consent

You may not qualify if…

• Required to take P2Y12 platelet inhibitor beyond 6 months when Amulet 2 LAA Occluder implant procedure would occur
• 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
• Atrial septal defect or patent foramen ovale repair or occluder
• Implanted with a mechanical valve prosthesis
• 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
• 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)
• Underwent catheter ablation for AF or atrial flutter within 60 days prior to when Amulet 2 device implant procedure would occur
• 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)
• 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
• Inferior vena cava filter present
• Left ventricular ejection fraction ≤30% (per most recent assessment)
• Experienced stroke or transient ischemic attack within 90 days prior to when Amulet 2 device implant procedure would occur
• Experienced myocardial infarction (with or without intervention) within 90 days prior to when Amulet 2 device implant procedure would occur
• New York Heart Association (NYHA) Class IV Congestive Heart Failure
• 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
• Underwent prior attempted endocardial, epicardial, or surgical LAA closure or occlusion, defined as deployment of a device or surgical procedure whether successful or unsuccessful
• Reversible cause of AF (i.e., secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
• History of idiopathic or recurrent venous thromboembolism within the past 5 years
• Thrombocytopenia (defined as < 50,000 platelets per microliter (<50 x 109/L) or anemia (defined as hemoglobin < 10 g/dL) requiring transfusions
• Known hypersensitivity to any portion of the device material or individual components of the Amulet 2 device (e.g., nickel allergy)
• 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.
• Is pregnant or breastfeeding, or pregnancy is planned during the course of the investigation
• Active endocarditis or other infection producing bacteremia
• Transient case of AF (i.e., never previously detected, provoked/induced by surgical or catheter manipulations, etc.)
• Severe renal failure (estimated glomerular filtration rate <30 ml/min/1.73m2) or on chronic dialysis

Where it is running

• 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

Full record on ClinicalTrials.gov

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