Study ID: Protected TAVR
Stroke protection with Sentinel during transcatheter aortic valve replacement
Researchers seek to determine if use of the FDA-approved Sentinel® Cerebral Protection System significantly reduces the risk of stroke in patients undergoing a transcatheter aortic valve replacement (TAVR). The Sentinel System captures and removes embolic material (e.g., blood clot, fat globule) during a TAVR and is meant to reduce ischemic injury to the brain.
Eligible study participants are those who have been diagnosed with aortic valve stenosis and are in need of a TAVR. All study participants undergoing a TAVR are randomized into one of two groups. The experimental arm will undergo a TAVR utilizing the Sentinel System. The other group, the control arm, will undergo a TAVR without utilization of the Sentinel System.
The study duration for each participant is expected to be through 72 hours or hospital discharge after the TAVR procedure (whichever comes first).
This prospective, post-market, multicenter, randomized and controlled trial is evaluating use of the FDA-approved Sentinel® Cerebral Protection System in subjects with aortic valve stenosis who are treated with a commercially available TAVR device. The trial seeks to demonstrate that use of the Sentinel® System significantly reduces the risk of peri-procedural stroke (≤72 hours) after TAVR.
The System is indicated for use as a cerebral protection device to capture and remove embolic material while performing a TAVR, thereby reducing the potential for an ischemic injury to the brain peri-procedurally.
Subjects to be treated via a transfemoral approach will be randomized 1:1 into either the Test cohort (TAVR using the Sentinel) or the Control cohort (TAVR without using the Sentinel). Subject must have the recommended artery diameter at the site of filter placement: 9-15 mm for the brachiocephalic artery, and 6.5-10 mm in the left common carotid artery.
The following conditions would exclude patients from participating in this trial:
- brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium
- compromised blood flow to the right upper extremity
- access vessels with excessive tortuosity
- uncorrected bleeding disorders
- contraindicated for anticoagulant and antiplatelet therapy
- Must have documented severe aortic valve stenosis and be a candidate for TAVR via transfemoral access
- Must not have arterial stenosis >70% in either the left common carotid artery or the brachiocephalic artery
- Other inclusion and exclusion criteria apply