Abbott Medical - VERITAS Study (NCT06707688) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Abbott Medical - VERITAS Study
United States, Belgium, Canada458 participantsStarted 2024-11-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is no longer enrolling new patients — does that mean I've missed the window to participate, or are there any related trials studying the Amiibo LAA closure device that I could still be considered for?
2The trial measures whether the LAA closure device successfully seals off the left atrial appendage at 45 days — what does it mean for my long-term stroke risk if the seal isn't complete, and how does that compare to staying on blood thinners?
3The primary safety window is only 7 days after the procedure — given that this is a Phase NA device study, how much do we actually know so far about longer-term safety, and what risks should I be aware of beyond that initial window?
4Since this trial involves a procedure to close off part of my heart rather than medication, how does the recovery and follow-up burden — including the required TEE imaging at 45 days — fit with my current health situation and daily life?
5Would my doctor consider standard blood-thinning medications or an already-approved LAA closure device like Watchman a better first option for me right now, given that the evidence from this specific trial is still being collected?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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.
. Subject is able and willing to return for required follow-up visits and protocol required clinical investigation activities
. 18 years of age or older, or the age of legal consent
Exclusion criteria
. 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)