To demonstrate that use of the SENTINEL™ Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).
This study will randomize =3,000 TAVR patients 1:1. With a group of patients protected with SENTINEL vs a group of the same size receiving no SENTINEL during the TAVR procedure. The PROTECTED TAVR Trial is an all-comers study. All risk categories will be eligible for inclusion, including low risk patients and all commercially available valves will be included as part of the trial.
The primary endpoint is all stroke (hemorrhagic, ischemic, or undetermined status; disabling or non-disabling) through 72h post TAVR procedure or discharge, whichever comes first.
Transient ischemic attack (TIA) and delirium will also be reported on as part of the secondary neurological endpoints.
All patients enrolled in the trial will undergo neurological examination at baseline and post procedure and through 72 hours after TAVR or discharge. This assessment will be performed by a neurology professional (board certified/board eligible neurologist, neurology fellow, neurology physician assistant, or neurology nurse practitioner).
SENTINEL Indication for Use
The SENTINEL Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures.
The diameters of the arteries at the site of filter placement should be between 9.0 mm – 15.0 mm for the brachiocephalic and 6.5 mm – 10.0 mm in the left common carotid.