Clinical Trial Details
Prospective, multi-center, randomized control trial Up to 1600 patients randomized.
1:1 randomization; Non-Inferiority CLAAS: Commercially available LAAO device outlined in protocol.
Up to 100 investigational sites in the United States and up to 15 sites in EU/Asia.
Primary Objective
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To evaluate the safety and effectiveness of the CLAAS AcuFORM Implant by demonstrating non-inferiority to currently marketed LAAO systems in subjects with non-valvular atrial fibrillation.
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To demonstrate the safety of a post procedure pharmacologic antiplatelet regimen that consists of DAPT alone without concomitant anticoagulation therapy.
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To demonstrate the ability to safely deliver the CLAAS AcuFORM Implant using a conscious sedation protocol without general anesthesia. To investigate this objective, a separate sub-study will be conducted after recruitment of the Randomized Control Trial (RCT) is complete at select, qualified sites based on the experience demonstrated in the RCT.
Patient Eligibility
The CLAAS AcuFORM Implant has been designed to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:
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Are at increased stroke/systemic embolism risk and are recommended for OAC (As defined by CHADS2/CHA2DS2-VASc);
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Physician determines the subject is suitable for short-term OAC use;
and
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Have an appropriate rationale to seek a non-pharmacological alternative to OAC (Risk-benefit of OAC vs device considered)
CONFORMAL
Early Feasibility Study
97.7% Closure Success
Seal without significant (>3mm) leaks at 12 months, comparing favorably with marketed devices.
1
Publications
Foam-Based Left Atrial Appendage Closure (CLAAS) Device: Evaluation in a Chronic Canine Model
The Conformal Left Atrial Appendage System (CLAAS) is a transcatheter implant designed to occlude the left atrial appendage to prevent stroke in patients with non-valvular atrial fibrillation.
Intracardiac Echocardiography Guided Left Atrial Appendage Closure With a Novel Foam-Based Conformable
Device Safety and 1-Year Outcomes.
Preclinical Assessment of a Novel Conformable Foam-Based Left Atrial Appendage Closure Device
Atrial Fibrillation is the most common cardiac arrhythmia and affects more than 5 million patients in the United States and 33 million worldwide.
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Gray W, Conformal Early Feasibility Study: 12 Months Results. TCT 2023
