Medical Specialties > Structural Heart > PROTECTED TAVR Study

Every patient deserves protection from disabling stroke

Safeguard quality of life for Transcatheter Aortic Valve Replacement (TAVR) patients in just four minutes2 per procedure. New data from the PROTECTED TAVR Study showed SENTINEL™ Cerebral Protection System (CPS) reduced the risk of disabling, perioperative stroke by 60% through 72-hours.1

 

The PROTECTED TAVR Study

Study Objectives

To demonstrate that use of the SENTINEL™ CPS significantly reduces the risk of peri-procedural stroke (≤ 72-hours) after TAVR.

Study Design

The PROTECTED TAVR Study is the largest randomized TAVR trial to date with 3,000 patients enrolled at >50 global sites who were randomized 1:1 – patients protected with SENTINEL vs. no use of SENTINEL during TAVR. All risk categories were eligible for inclusion, including low risk patients and all commercially available valves included as part of the trial.
Primary Endpoint: All Stroke  (hemorrhagic, ischemic, or undetermined status; disabling or non-disabling) through 72-hours post TAVR procedure or hospital discharge.
Transient ischemic attack (TIA) and delirium were also reported on as part of the secondary neurological endpoints.
All patients enrolled in the trial underwent neurological examination at baseline and post TAVR procedure (discharge or 72-hours, whichever came first). This assessment was performed by a neurology professional (board certified/board eligible neurologist, neurology fellow, neurology physician assistant, or neurology nurse practitioner).
SENTINEL stroke risk study
*Any commercially available TAVR device; ‡ Neurological examination at baseline, and post-procedure and through 72 hours after TAVR or discharge (whichever comes first), performed by a neurology professional (board certified/board eligible neurologist, neurology fellow, neurology physician assistant, or neurology nurse practictioner)
 

PROTECTED TAVR Results

The SENTINEL™ CPS showed a reduced risk of disabling, perioperative stroke by 60% through 72-hours.1
 

Disabling Stroke

Relative risk reduction through 72-hours
60% relative risk reduction through 72-hours in disabling stroke
 

The primary endpoint did not meet statistical significance, but the data demonstrated a numerical trend towards a lower rate of stroke in patients treated with the SENTINEL device, representing a 21% relative risk reduction in all stroke through 72-hours or time of hospital discharge.

A secondary analysis demonstrated a statistically significant 60% relative risk reduction in disabling stroke through 72-hours or time of hospital discharge in patients treated with the SENTINEL device.

 
All Stroke vs. Disabling Stroke chart
 
 

Strong safety profile

The SENTINEL CPS demonstrated excellent safety with high rates of device delivery/retrieval (94.4%) and very low rates of vascular complications (0.1%).1
94%

Safe & Effective Device Delivery

 
0.1%

Low Access Site Complications

 
 

Stroke persists as an indiscriminate risk

It is impossible to predict which TAVR procedures will dislodge embolic debris, and when it will cause disabling stroke. 

Every patient is a candidate for protection from disabling stroke

The patient subgroup analysis demonstrated that almost every patient population benefitted from protection with SENTINEL CPS.
 
 

Any occurence of stroke is one too many

Life-changing. Far-reaching. Expensive. The impacts of post-TAVR disabling stroke create a ripple effect of consequences.
 

 
 
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