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Clinical Trials in Germany / NCT06707688
Active, not recruiting Not applicable

Abbott Medical - VERITAS Study

NCT06707688 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2024-11-07
Last updated
2026-08-04

Condition(s) studied

Atrial Fibrillation (AF)Stoke

Investigational drug(s) / intervention(s)

Amulet™ 2 Left Atrial Appendage (LAA) Occluder

Amulet™ 2 Left Atrial Appendage (LAA) Occluder: Patient will undergo the implantation of the Amulet™ 2 Left Atrial Appendage (LAA) Occluder

Study 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

Sex
ALL
Min age
18 Years
Max age
—
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 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 outcome measure(s)

Trial sites (35)

FacilityCityRegionStatus
Arizona Arrhythmia Research Group Phoenix Arizona
Arrhythmia Research Group Jonesboro Arkansas
Baptist Medical Center Jacksonville Florida
AdventHealth Orlando Orlando Florida
Northside Hospital Atlanta Georgia
Kansas City Cardiac Arrhythmia Research Foundation Overland Park Kansas
Henry Ford Providence Southfield Hospital Southfield Michigan
Mayo Clinic Rochester Minnesota
CHI Health Creighton University Medical Center-Bergan Mercy Omaha Nebraska
NYU Langone Health New York New York
Mount Sinai Hospital New York New York
Roper Hospital Charleston South Carolina
Trident Medical Center Charleston South Carolina
Vanderbilt Heart & Vascular Institute Nashville Tennessee
Texas Cardiac Arrhythmia Austin Texas
Baylor Scott & White All Saints Medical Center Fort Worth Texas
Vital Heart and Vein Humble Texas
Baylor Scott & White - The Heart Hospital Plano Plano Texas
Heart Rhythm Associates Shenandoah Texas
Hôpital Civil Marie Curie Lodelinsart Belgium
University of Ottawa Heart Institute Ottawa Ontario
Institut de Cardiologie de Montreal (Montreal Heart Inst.) Montreal Quebec
Aarhus Universitetshospital Aarhus Denmark
Rigshospitalet Copenhagen Denmark
CHU Gabriel Montpied Clermont-Ferrand Auvergn
Institute Cardio. Paris-Sud - Institut Jacques Cartier Massy France
Cardioangiologisches Centrum am Bethanien Krankenhaus Frankfurt am Main Hesse
Deutsches Herzzentrum der Charité Berlin Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck Lübeck Germany
Heinrich-Braun-Klinikum gemeinnützige gGmbH Standort Zwickau Zwickau Germany
Ospedale San Raffaele Milan Italy
Hospital Clínic de Barcelona Barcelona Spain
Hospital Clinico San Carlos Madrid Spain
Hospital Universitario de Salamanca Salamanca Spain
Center Inselspital Bern Bern Canton of Bern

More Abbott Medical Devices trials in Germany

VOLT CE Mark Study Active, not recruiting
MitraClip REPAIR MR Study Active, not recruiting
Amplatzer Amulet LAAO vs. NOAC Active, not recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06707688 on ClinicalTrials.gov ↗ ← All trials in Germany