ACTIVE_NOT_RECRUITING

Abbott Medical - VERITAS Study

Conditions

Atrial Fibrillation (AF)Stoke Left Atrial Appendage LAA Occluder Afib Amulet Abbott VERITAS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Abbott Medical - VERITAS Study

Quick Facts

Study Start:2024-11-11

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06707688

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Principal Investigator

Ryan Palmer

STUDY_DIRECTOR

Abbott Medical

Devi Nair, MD

PRINCIPAL_INVESTIGATOR

Arrhythmia Research Group

Mohamad Alkhouli, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Arizona Arrhythmia Research Group

Phoenix, Arizona, 85016

United States

Arrhythmia Research Group

Jonesboro, Arkansas, 72401

United States

Baptist Medical Center

Jacksonville, Florida, 32207

United States

AdventHealth Orlando

Orlando, Florida, 32803

United States

Northside Hospital

Atlanta, Georgia, 30342

United States

Kansas City Cardiac Arrhythmia Research Foundation

Overland Park, Kansas, 66211

United States

Providence Hospital

Southfield, Michigan, 48075

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

CHI Health Creighton University Medical Center-Bergan Mercy

Omaha, Nebraska, 68124

United States

NYU Langone Health

New York, New York, 10016

United States

Mount Sinai

New York, New York, 10019

United States

Roper Hospital

Charleston, South Carolina, 29401

United States

Trident Medical Center

Charleston, South Carolina, 29406

United States

Vanderbilt Heart & Vascular Institute

Nashville, Tennessee, 37232

United States

Texas Cardiac Arrhythmia

Austin, Texas, 78705

United States

Baylor All Saints Medical Center at Fort Worth

Fort Worth, Texas, 76104

United States

Vital Heart and Vein

Humble, Texas, 77338

United States

The Heart Hospital Baylor Plano

Plano, Texas, 75093

United States

Heart Rhythm Associates

Shenandoah, Texas, 77380

United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

Ryan Palmer, STUDY_DIRECTOR, Abbott Medical
Devi Nair, MD, PRINCIPAL_INVESTIGATOR, Arrhythmia Research Group
Mohamad Alkhouli, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-11

Study Completion Date2027-09

Study Record Updates

Study Start Date2024-11-11

Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

Left Atrial Appendage
LAA Occluder
Afib
Amulet
Abbott
VERITAS

Additional Relevant MeSH Terms

Atrial Fibrillation (AF)
Stoke