Claret Medical's SENTINEL Pivotal Trial Evaluates Cerebral Protection During TAVR

October 6, 2014—Claret Medical, Inc. announced that the first patient has been enrolled in its SENTINEL trial in the United States. SENTINEL is a multicenter pivotal trial of the company’s Sentinel cerebral protection system (CPS). The prospective, randomized, controlled, blinded trial will evaluate the role of cerebral protection during transcatheter aortic valve replacement (TAVR). Susheel Kodali, MD, a national coprincipal investigator for the trial, successfully treated the patient at New York and Presbyterian Hospital/Columbia University Medical Center in New York City.

According to Claret Medical, the SENTINEL trial will evaluate up to 284 patients at up to 15 centers nationwide. The trial’s primary endpoints are the reduction in total new lesion volume as determined by diffusion-weighted magnetic resonance imaging and major adverse cardiac and cerebrovascular events. A number of secondary endpoints, such as neurocognitive and histopathological outcomes during TAVR, will be compared in the study arms with and without cerebral protection.

In the company’s press release, Samir Kapadia, MD, commented, “Any occurrence of stroke is one too many, and results from this clinical trial may give us the evidence needed to make cerebral protection a standard of care during TAVR, as it is in carotid artery stenting. By both capturing and removing embolic debris released during TAVR, the Sentinel CPS may offer a unique neuroprotective benefit. We expect the device to demonstrate a similarly significant reduction in the number and size of lesions in the brains of TAVR patients when cerebral protection is used as was recently reported in the CLEAN-TAVI trial.” Dr. Kapadia, who serves as a national coprincipal investigator for the study, is Director of the Sones Cardiac Catheterization Laboratories at the Cleveland Clinic in Cleveland, Ohio.

In September, Axel Linke, MD, presented 30-day results from the CLEAN-TAVI trial at the 26th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC. 

The CLEAN-TAVI (Claret Embolic Protection and Transcatheter Aortic Valve Implantation) study found that using the Claret system can significantly reduce the number and volume of cerebral lesions in high-risk patients with severe aortic stenosis. The data showed a 53% reduction in the total volume of new brain lesions and a 60% reduction in the number of new brain lesions 2 days after the TAVR procedure when the Claret CPS was used. Additionally, there was a 24% incidence of the neurological symptoms of ataxia in the control group as compared to 9% in the treatment group protected with the Claret system in a per protocol analysis at 2 days, which reached statistical significance. An observed neurological deficit in 28% of all control patients at 2 days postprocedure (when evaluated by a specialist trained in the National Institutes of Health Stroke Scale) in an intent-to-treat analysis demonstrated that prospective assessment pre- and postprocedure can identify more neurological effects than have been reported to date, stated the company.