Abbott Medical - VERITAS Study

NCT06707688 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: ABT-CIP-10523G240218
• Study Type: interventional
• Target: 458
• Locations: 9 countries
• Sites: 35

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.

Conditions

Atrial Fibrillation (AF); Stoke

Keywords

Left Atrial Appendage; LAA Occluder; Afib; Amulet; Abbott; VERITAS

Outcome Measures

Primary Outcomes (2)

• The primary safety endpoint is the occurrence of any prespecified safety events through 7 days post-procedure or hospital discharge, whichever is later.

  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.

  7 days post-procedure or hospital discharge

• 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.

  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.

  45 days

Secondary Outcomes (1)

• The secondary effectiveness endpoint is the composite of ischemic stroke or systemic embolism at 24 months.

  24 months

Study Arms (1)

Amulet™ 2 Left Atrial Appendage (LAA) Occluder

EXPERIMENTAL

Transcatheter left atrial appendage (LAA) occluder

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

Interventions

Amulet™ 2 Left Atrial Appendage (LAA) Occluder DEVICE

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

Amulet™ 2 Left Atrial Appendage (LAA) Occluder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older, or the age of legal consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (35)

Arizona Arrhythmia Research Group

Phoenix, Arizona, 85016, United States

Location

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

Baptist Medical Center

Jacksonville, Florida, 32207, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Kansas City Cardiac Arrhythmia Research Foundation

Overland Park, Kansas, 66211, United States

Location

Henry Ford Providence Southfield Hospital

Southfield, Michigan, 48075, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

CHI Health Creighton University Medical Center-Bergan Mercy

Omaha, Nebraska, 68124, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Mount Sinai Hospital

New York, New York, 10019, United States

Location

Roper Hospital

Charleston, South Carolina, 29401, United States

Location

Trident Medical Center

Charleston, South Carolina, 29406, United States

Location

Vanderbilt Heart & Vascular Institute

Nashville, Tennessee, 37232, United States

Location

Texas Cardiac Arrhythmia

Austin, Texas, 78705, United States

Location

Baylor Scott & White All Saints Medical Center

Fort Worth, Texas, 76104, United States

Location

Vital Heart and Vein

Humble, Texas, 77338, United States

Location

Baylor Scott & White - The Heart Hospital Plano

Plano, Texas, 75093, United States

Location

Heart Rhythm Associates

Shenandoah, Texas, 77380, United States

Location

Hôpital Civil Marie Curie

Lodelinsart, Belgium

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K18 4W7, Canada

Location

Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Quebec, Canada

Location

Aarhus Universitetshospital

Aarhus, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

CHU Gabriel Montpied

Clermont-Ferrand, Auvergn, France

Location

Institute Cardio. Paris-Sud - Institut Jacques Cartier

Massy, France

Location

Cardioangiologisches Centrum am Bethanien Krankenhaus

Frankfurt am Main, Hesse, Germany

Location

Deutsches Herzzentrum der Charité

Berlin, Germany

Location

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Germany

Location

Heinrich-Braun-Klinikum gemeinnützige gGmbH Standort Zwickau

Zwickau, Germany

Location

Ospedale San Raffaele

Milan, Italy

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Spain

Location

Center Inselspital Bern

Bern, Switzerland

Location

Related Publications (1)

• Nair D, Freixa X, Ellis CR, Lakkireddy D, Nielsen-Kudsk JE, Horton R, Reddy VY, Makkar A, Ibrahim R, Agarwal H, de Backer O, Sabir S, Weiler C, Alkhouli M; VERITAS Investigators. Early Outcomes With a Next-Generation Dual-Seal Left Atrial Appendage Occluder: Results From the VERITAS Study. JACC Clin Electrophysiol. 2026 Feb 6:S2405-500X(26)00028-9. doi: 10.1016/j.jacep.2026.01.021. Online ahead of print.

  PMID: 41701134 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ryan Palmer

  Abbott Medical

  STUDY DIRECTOR

• Devi Nair, MD

  Arrhythmia Research Group

  PRINCIPAL INVESTIGATOR

• Mohamad Alkhouli, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 27, 2024
• Study Start: November 7, 2024
• Primary Completion: November 6, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2); ES (3); DE (4); US (19); CH (1); IT (1); FR (2); BE (1); CA (2)