CLEAN-TAVI Trial Results Could See Embolic Protection Become Standard in TAVR

It’s that time of year again when the eyes of the cardiology world are on the specialty we can always rely on to be the fastest developing of them all. It’s Transcatheter Cardiovascular Therapeutics (TCT) 2014, the 26th holding of the congress, this time in Washington DC.

News from the event sees Claret Medical™ enjoying good news about its cerebral protection system, announcing that the CLEAN-TAVI Trial met its primary endpoint by demonstrating that using the device resulted in significantly reduced quantity and volume of brain lesions detected by a serial review of magnetic resonance imaging (MRI) following transcatheter aortic valve replacement (TAVR).

Background

Earlier in September we reported that the CLEAN-TAVI trial had completed enrollment. CLEAN-TAVI is a prospective, double blinded, 1:1 randomized controlled trial enrolling 100 patients indicated for transfemoral aortic valve implantation with the Medtronic CoreValve®, where the Claret system was used for cerebral protection. The system is the only one to both capture and remove embolic debris that might otherwise travel to the brain during TAVR.

The study was conducted using a 3-Tesla MRI system, which provides higher sensitivity in visualizing lesions, and the data was analyzed blindly by the independent Buffalo Neuroimaging Analysis Center MRI core lab. The trial was conducted at the University of Leipzig, Germany, and evaluates mechanistic and clinical outcomes at two, seven, 30 and 365 days post-procedure.

The results, reported by Professor Axel Linke, MD in a Late Breaking Clinical Trial session, showed a 53 percent reduction in the total volume of new brain lesions and a 60 percent reduction in the number of new brain lesions two days after the procedure.

At two days post-TAVR in the “Intent to Treat” analysis, a neurological deficit was observed in 28 percent of all control patients when evaluated by a NIHSS (National Institute of Health Stroke Scale) trained specialist, demonstrating that prospective assessment pre- and post-procedure can identify more neurological effects than has been reported to date. Importantly, the “Per Protocol” analysis at two days showed a statistically significantly lower ataxia rate of 24 percent versus nine percent in favor of the treatment group protected with the Claret Medical technology.

The study results showed a 60% reduction in the number of brain lesions vs. unprotected TAVR and a 53% reduction in the volume of those lesions at 30 days.

Taking all that into consideration, it’s difficult to come down anything other than in favour of the use of filtration to protect the cerebral vasculature. We already knew TAVR was associated with a heightened stroke risk due to embolic debris. This study has fine-tuned that knowledge and reinforced it significantly. Moreover it’s also determined that the proposed solution of an in-line peri-operative filter works.

Investigator comments

“The results seen with the Claret Medical system are striking,” said Professor Axel Linke, MD, of the University of Leipzig, principal investigator for CLEAN-TAVI. “They clearly show that by removing embolic debris from cerebral circulation when performing TAVR we can dramatically reduce both the quantity and volume of brain lesions.”

Company comments

“The CLEAN-TAVI outcomes validate our expectations that filter-based cerebral protection has the potential to improve neurological outcomes and enable a safer TAVR procedure, which will be necessary for the procedure to expand to lower risk populations,” said Claret Medical Chief Executive Officer and President Azin Parhizgar, PhD.

Source: Claret Medical

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