Atrial Fibrillation (AF), Stoke
Conditions
Keywords
Left Atrial Appendage, LAA Occluder, Afib, Amulet, Abbott, VERITAS
Brief summary
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.
Interventions
DEVICEAmulet™ 2 Left Atrial Appendage (LAA) Occluder
Patient will undergo the implantation of the Amulet™ 2 Left Atrial Appendage (LAA) Occluder
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary safety endpoint is the occurrence of any prespecified safety events through 7 days post-procedure or hospital discharge, whichever is later. | 7 days post-procedure or hospital discharge | The primary safety endpoint is the occurrence of any of the following events through 7 days post-procedure or hospital discharge, whichever is later: death, ischemic stroke, systemic embolism, or device/procedure related complications requiring open cardiac surgery or major endovascular intervention. Device/procedure related events contributing to the primary endpoint may include pseudoaneurysm or AV fistula repair, whereas percutaneous drainage of pericardial effusion, snaring of embolized devices, thrombin injection or nonsurgical treatment of access site complications will not contribute to the primary endpoint. |
| 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. | 45 days | The primary effectiveness endpoint is LAA occlusion defined as no peri-device flow or peri-device flow ≤5mm based on Doppler color flow TEE/TOE at the 45-day follow-up visit as assessed by an independent core laboratory. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The secondary effectiveness endpoint is the composite of ischemic stroke or systemic embolism at 24 months. | 24 months | The secondary effectiveness endpoint is the composite of ischemic stroke or systemic embolism at 24 months. |
Countries
Belgium, Canada, Denmark, France, Germany, Italy, Spain, Switzerland, United States
Contacts
STUDY_DIRECTORRyan Palmer
Abbott Medical
PRINCIPAL_INVESTIGATORDevi Nair, MD
Arrhythmia Research Group
PRINCIPAL_INVESTIGATORMohamad Alkhouli, MD
Mayo Clinic
Outcome results
None listed