Enrollment Begins for Neovasc's TIARA-I Clinical Trial

December 1, 2014—Neovasc Inc. announced that the first patient has been enrolled in the European arm of its TIARA-I early feasibility trial. The Tiara valve implantation was completed via a minimally invasive, transapical, transcatheter approach.

According to the company, TIARA-I is a multinational, multicenter trial being conducted at centers in the United States, Europe, and Canada to assess the safety and performance of Neovasc’s Tiara mitral valve system and implantation procedure in high-risk surgical patients who have severe mitral regurgitation (MR). 

Stefan Verheye, MD, enrolled the trial’s first patient at the Antwerp Cardiovascular Center/ZNA Middelheim, Belgium. The procedure resulted in elimination of the patient’s MR without leaks or other complications. To date, recovery of the patient has been uneventful, stated the company.

In October, the company announced investigational device exemption approval from the US Food and Drug Administration for the United States arm of the TIARA-I trial.

In the United States, TIARA-I has received institutional review board approval from the first of the participating medical centers, and it is anticipated that implantations of Tiara will begin in the coming months. The company expects that additional European and Canadian sites will begin enrolling patients in early 2015.

Neovasc also confirmed that in November, Tiara was implanted in a fourth Canadian patient at St. Paul’s Hospital in Vancouver, Canada, under Special Access (compassionate use) regulatory approval. This implantation was completed uneventfully and resulted in a well-functioning prosthetic valve with no residual MR, leaks, or other complications. The patient was discharged home on day 5 after implantation, and their recovery has been uneventful to date.