Device: Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems · Device: Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
Device: Arm 1: treatment with Shockwave Reducer · Other: Arm 2 (control): Implantation procedure with no device implanted · Device: Arm 3 (unblinded, non-randomized): Single arm registry