Clinical trial NCT06707688: Abbott Medical - VERITAS Study
Official title: Abbott Medical - VERITAS Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Stoke
Keywords: Left Atrial Appendage
LAA Occluder
Afib
Amulet
Abbott
VERITAS
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2024-11-27
Enrollment: 475
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary safety endpoint is the occurrence of any prespecified safety events through 7 days post-procedure or hospital discharge, whichever is later.
timeFrame: 7 days post-procedure or hospital discharge
measure: 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.
timeFrame: 45 days
Secondary outcomes:
measure: The secondary effectiveness endpoint is the composite of ischemic stroke or systemic embolism at 24 months.
timeFrame: 24 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Arrhythmia Research Group
state: Arizona
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Overland Park
country: United States
facility: Kansas City Cardiac Arrhythmia Research Foundation
state: Kansas
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Omaha
country: United States
facility: CHI Health Creighton University Medical Center-Bergan Mercy
state: Nebraska
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Charleston
country: United States
facility: Roper Hospital
state: South Carolina
city: Charleston
country: United States
facility: Trident Medical Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Heart & Vascular Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia
state: Texas
city: Fort Worth
country: United States
facility: Baylor All Saints Medical Center at Fort Worth
state: Texas
city: Humble
country: United States
facility: Vital Heart and Vein
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Shenandoah
country: United States
facility: Heart Rhythm Associates
state: Texas
city: Lodelinsart
country: Belgium
facility: Hôpital Civil Marie Curie
city: Vancouver
country: Canada
facility: Vancouver General Hospital (U of BC)
state: British Columbia
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
state: Ontario
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)
state: Quebec
city: Arhus
country: Denmark
facility: Skejby University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Clermont-Ferrand
country: France
facility: CHU Gabriel Montpied
state: Auvergn
city: Massy
country: France
facility: Institute Cardio. Paris-Sud - Institut Jacques Cartier
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum am Bethanien Krankenhaus
state: Hesse
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité
city: Köln
country: Germany
facility: Eduardus Hospital
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck
city: Zwickau
country: Germany
facility: Heinrich-Braun-Klinikum gemeinnützige gGmbH Standort Zwickau
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Zabrze
country: Poland
facility: Slaskie Centrum Chorob Serca
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Bern
country: Switzerland
facility: Center Inselspital Bern
Study officials:
affiliation: Abbott Medical
name: Ryan Palmer
role: STUDY_DIRECTOR
affiliation: Arrhythmia Research Group
name: Devi Nair, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Mohamad Alkhouli, MD
role: PRINCIPAL_INVESTIGATOR
References: