Enrollment Completed in CLEAN-TAVI Trial of Claret Medical's Cerebral Protection System

September 4, 2014—Claret Medical, Inc. announced completion of enrollment in the CLEAN-TAVI (Claret Embolic Protection and Transcatheter Aortic Valve Implantation) clinical trial studying its filter-based cerebral protection system (CPS). The company advised that results from CLEAN-TAVI will be presented on September 13 as a late breaking clinical trial at TCT 2014: Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC.

The Claret Medical CPS is a filter-based device that both captures and removes embolic debris released during transcatheter aortic valve replacement (TAVR) procedures that could otherwise be a source of acute stroke. 

According to the company, the trial was designed as a first-of-its-kind, randomized controlled trial powered to definitively demonstrate the importance of cerebral protection in reducing the number and volume of new cerebral lesions created by debris lodged in the brain as a result of TAVR.          

CLEAN-TAVI is a prospective, single-blind, randomized controlled trial of 100 patients treated with the Medtronic CoreValve and using the Claret Medical filter-based system for cerebral protection. The trial was conducted at the University of Leipzig, with Professor Axel Linke, MD, as the lead investigator.

The efficacy outcomes reported will be the difference in the volume and number of embolic lesions detected in the brain pre- and post-TAVR procedure, with or without the use of cerebral protection, through a serial review of magnetic resonance imaging (MRI) performed over time.

The MRI scans will be assessed blindly by an independent core lab overseen by Robert Zivadinov, MD, of the Buffalo Neuroimaging Analysis Center in Buffalo, New York.

Renu Virmani, MD, at CVPath Institute of Pathology in Gaithersburg, Maryland, will perform an evaluation of patients’ neurological and neurocognitive functions and will conduct a blinded histopathological review of the captured debris. The trial will evaluate outcomes at 2, 7, and 30 days postprocedure, and at 1 year.

 “CLEAN-TAVI is a landmark clinical trial, and we expect it to be the first to show a reduction in brain lesions associated with TAVR when cerebral protection is used,” commented Professor Linke in the company’s press release. “As TAVR patients get younger and healthier, it will be unacceptable for the stroke rate to remain where it is today or for us to ignore the resulting neurocognitive decline associated with these lesions in the brain. This study may have significant implications for the expansion of TAVR into new patient populations in the years to come.”

The company also announced that it has initiated the SENTINEL-H postmarket observational study evaluating its latest generation cerebral protection system, the Sentinel CPS.

SENTINEL-H is a core-lab adjudicated study enrolling up to 250 patients at 10 to 15 centers across Europe. The study is designed to evaluate the effectiveness of the Sentinel CPS in capturing debris during TAVR procedures. The primary endpoint of the study is the rate of capture and histomorphometric analysis of the embolic debris, including total and per-filter embolic debris volume lodged in the right and left carotid arteries, as well as characterization of the embolic material. The SENTINEL-H study’s Principal Investigator is Christoph Naber, MD, an associate professor at Essen University Hospital in Essen, Germany. Peter Frambach, MD, treated the first patient at the Centre Hospitalier de Luxembourg in Luxembourg City.

Earlier this year, the company received investigational device exemption approval from the US Food and Drug Administration to begin a United States pivotal trial of the Sentinel CPS. The trial is expected to begin patient enrollment shortly, advised Claret Medical.