TRiCares SAS has enrolled and treated the first patient in its TRICURE US IDE pivotal study of the Topaz transcatheter tricuspid valve replacement (TTVR) system.

It is said to be the first randomised controlled trial to directly compare an investigational TTVR device with the commercially available Edwards EVOQUE TTVR system in a head-to-head manner.

The multi-centre, global, prospective trial will assess the safety and effectiveness of the TRiCares Topaz system in patients with severe or greater tricuspid regurgitation who are suitable for valve replacement.

Study sites will include locations in Canada, the US, and several European countries, involving up to 75 centres in total.

The first patient was enrolled at Piedmont Heart Institute in Atlanta, Georgia, US.

The treatment was led by Piedmont Heart Institute Marcus Heart and Vascular Center Structural Interventions director and TRICURE US pivotal study co-principal investigator Dr Pradeep Yadav, alongside cardiac surgery chairman and site principal investigator Dr Vinod Thourani.

TRiCares president and CEO Ahmed Elmouelhi said: “Initiating our TRICURE US IDE pivotal study represents a defining moment for TRiCares following years of innovation by our dedicated team. This milestone positions us ahead of the curve in demonstrating Topaz’s transformative potential in today’s treatment paradigm.

“As we rapidly activate new investigative sites and build enrolment momentum - in parallel with our ongoing European pivotal study - we are moving closer to our ambition of establishing Topaz as the preferred treatment option for TR patients globally.”

Topaz is being assessed as part of an international clinical programme that includes the ongoing US early feasibility study and the TRICURE European Pivotal Study.

The European study is currently recruiting participants across Belgium, Canada, Denmark, Germany, France and Spain, with Switzerland expected to follow.