PROTECT H2H Directly Compares Stroke Protection Devices During TAVR 

April 12, 2026—The American College of Cardiology (ACC) announced that findings from the PROTECT H2H randomized trial were presented at the ACC.26 annual scientific session.

The ACC press release stated that PROTECT H2H directly compared the safety and effectiveness of the Emboliner embolic protection system (Emboline, Inc.) versus the Sentinel cerebral protection system (Boston Scientific Corporation) in patients undergoing transcatheter aortic valve replacement (TAVR) procedures. Emboline funded the study.

According to the ACC, PROTECT H2H enrolled 522 patients who were randomly assigned to undergo TAVR with protection provided by either the Emboliner or the Sentinel device in the United States, Germany, and Brazil. All patients had severe aortic stenosis patients, the average age was 79 years, and 33% were women.

The ACC press release noted that the Emboliner system is an investigational full-body filter designed to capture TAVR-generated debris and prevent it from getting into the arteries that carry blood not only to the brain but also to other organs and tissues.The Sentinel system is approved by the FDA for use with a TAVR catheter to capture the TAVR-generated debris and keep it from getting into the bloodstream and to the brain.

PROTECT H2H showed similar outcomes for patients receiving the Emboliner versus the Sentinel device in terms of the primary endpoint of composite of death from any cause, stroke, or kidney failure within 30 days of the procedure (4.9% vs 5.0%); in the secondary endpoints of stroke within 30 days (2.0% vs 2.1%); and in the number of adverse events such as bleeding and blood clots.

Notable differences included that the Emboliner captured more debris particles > 150 microns (93 vs 31), and more total particles (1,575 vs 801), including some as small as 40 microns. The Emboliner also had fewer issues with placement (4% vs 13%), stated the ACC press release.