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Medical Specialties > Structural Heart > ACURATE IDE Trial > Prime XL Nested Registry

Please note that the information included on this page is only intended for patients who may receive the ACURATE Prime™ Aortic Valve XL as part of the ACURATE IDE Clinical Trial.

ACURATE Prime™ XL Nested Registry

  • A non-randomized, nested registry cohort within the ACURATE IDE Clinical Trial that consists of subjects who will receive the ACURATE Prime™ Aortic Valve XL.
  • There will be 50 subjects at up to 20 centers currently participating in the main ACURATE IDE Clinical Trial in the United States enrolled in this registry.
 

Patient Population

  • Severe aortic valve stenosis.
  • Subjects who have a documented aortic annulus size of ≥26.5 mm and ≤29 mm (perimeter-derived diameter) based on pre-procedure diagnostic imaging.
  • All other criteria are the same as the main IDE cohorts.

ACURATE Prime™ Aortic Valve XL

  • The ACURATE Prime™ Aortic Valve XL is an iteration of the CE Mark-approved ACURATE neo2™ Aortic Valve.
  • The ACURATE Prime™ Aortic Valve XL allows easier removal of a fully loaded valve and is intended to optimize radial force with the addition of connected links.
 
Valve Size ACURATE Prime™ XL - 29mm
Aortic Annulus Perimeter Derived Diameter (mm) 26.5 < annulus ≤ 29
Aortic Annulus Perimeter (mm) 83 < annulus ≤ 91
 

ACURATE Prime™ Transfemoral Delivery System XL

The ACURATE Prime™ Transfemoral (TF) Delivery System XL is a slightly modified version of the ACURATE neo2™ Transfemoral Delivery System.
 
ACURATE Prime™ Transfemoral (TF) Delivery System XL
 
The system is compatible with the 14F iSLEEVE introducer and has a new distal release mechanism to allow quicker final valve release in one motion and improved valve detachment.
 
compatible with the 14F iSLEEVE
 
The ACURATE Prime™ TF Loading Kit XL is packaged separately from the delivery system and has been modified to accommodate the XL valve.
 

Timeline

After the procedure, the trial outcome measures for participants and the valves will be regularly evaluated.
Timeline
 
Please note that this is the same schedule of assessments that the subjects are currently following in the ACURATE IDE Clinical Trial.
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