Abbott Medical - VERITAS Study

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation (AF); Stoke

• Registration Number: NCT06707688
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-25
• Study First Posted: 2024-11-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-07
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 475

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (40)

Heart Rhythm Associates; 🇺🇸 Shenandoah, Texas, United States

Cliniques Universitaires Saint Luc; 🇧🇪 Brussels, Belgium

Hôpital Civil Marie Curie; 🇧🇪 Lodelinsart, Belgium

Vancouver General Hospital (U of BC); 🇨🇦 Vancouver, British Columbia, Canada

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

Kansas City Cardiac Arrhythmia Research Foundation; 🇺🇸 Overland Park, Kansas, United States

Providence Hospital; 🇺🇸 Southfield, Michigan, United States

Northside Hospital; 🇺🇸 Atlanta, Georgia, 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; 🇺🇸 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 All Saints Medical Center at Fort Worth; 🇺🇸 Fort Worth, Texas, United States

Vital Heart and Vein; 🇺🇸 Humble, Texas, United States

The Heart Hospital Baylor Plano; 🇺🇸 Plano, Texas, United States

Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada

Institut de Cardiologie de Montreal (Montreal Heart Inst.); 🇨🇦 Montreal, Quebec, Canada

Skejby University Hospital; 🇩🇰 Arhus, 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, Hesse, Germany

Deutsches Herzzentrum der Charité; 🇩🇪 Berlin, Germany

Eduardus Hospital; 🇩🇪 Köln, Germany

Universitätsklinikum Schleswig-Holstein - Campus Lübeck; 🇩🇪 Lübeck, Germany

Heinrich-Braun-Klinikum gemeinnützige gGmbH Standort Zwickau; 🇩🇪 Zwickau, Germany

Ospedale San Raffaele; 🇮🇹 Milano, Italy

Slaskie Centrum Chorob Serca; 🇵🇱 Zabrze, Poland

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet De Llobregat, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Center Inselspital Bern; 🇨🇭 Bern, Switzerland