Abbott Medical - VERITAS Study

Abbott

Status

Enrolling

Conditions

Stoke

Atrial Fibrillation (AF)

Treatments

Device: Amulet™ 2 Left Atrial Appendage (LAA) Occluder

Study type

Interventional

Funder types

Industry

Identifiers

NCT06707688

G240218 (Other Identifier)

ABT-CIP-10523

Details and patient eligibility

About

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.

Enrollment

475 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
Life expectancy is less than 2 years in the opinion of the Investigator
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:

Intracardiac thrombus
Existing circumferential pericardial effusion >2 mm
Mitral valve stenosis, defined as a mitral valve area of <1.5 cm2
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)
Complex atheroma of the descending aorta and/or aortic arch, defined as plaque >4 mm in thickness, plaque ulceration, and/or mobile lesions
Cardiac tumor
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)
Placement of the device would damage or interfere with the function of any intracardiac or intravascular structure