PARADIGM Trial

PARADIGM Trial

PARADIGM: A Prospective rAndomized tRial Assessing the safety and effectiveness of the DurAVR® bIomimetic valve designed for physioloGic flow compared to coMmercial TAVR devices

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Aortic stenosis
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All genders
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No minimum age

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Overview
Principal Investigator: Charles Resor, MD

To demonstrate non-inferiority of the DurAVR™ Transcatheter Heart Valve (THV) System compared with standard transcatheter aortic valve replacement (TAVR) for treatment of patients with severe AS. Prospective, randomized, controlled, multicenter, international study. Patients will be randomized 1:1 to receive either TAVR using the DurAVR™ THV System or TAVR using any commercially available and approved THV from the SAPIEN series Edwards Lifesciences, or the Evolut series, Medtronic. Patients with a failed surgical bioprosthesis and who need valve-in-valve (ViV) TAVR will be enrolled in a separate parallel registry.

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Charles Resor, MD

Study details
Inclusion Criteria
  • The patient is a candidate for TAVR using any of the devices included in study (the DurAVR™ THV System, SAPIEN series, Evolut THV Systems.
  • Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
  • Understands the study requirements and the treatment procedures and provides written informed consent
Exclusion Criteria
  • 1. Native aortic annulus size unsuitable for study THVs (investigational and control) based on 3D imaging analysis
    2. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
  • 3. Aortic valve (AV) is unicuspid, bicuspid, or is non-calcified
    4. Severe aortic regurgitation (>3+)
  • 5. Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis
    6. Left ventricular systolic dysfunction with LVEF < 30%
Study Requirements

Patients will be followed through 10 years with assessments at 30 days, 12 months, and annually thereafter. The expected study enrollment Phase is 12 months, and the expected study duration is up to 12 years. Blood collections may be performed at screening/baseline, Post Procedure (≤ 48h post-implant), Discharge (if > 48h post-procedure), 1 Year (± 30 Days). Chest X-Ray and CT scan may be performed at screening/baseline.