TriCares Begins TRICURE EU Pivotal Study of Topaz Valve

September 24, 2024—TriCares SAS has announced the first implantation of its Topaz transfemoral tricuspid heart valve replacement system in a pivotal study in Europe.

TRICURE EU is the company’s European pivotal study being conducted at clinical sites in Germany, Belgium, France, and Switzerland, with additional countries expected to follow.

According to TriCares, the study will assess the safety and efficacy of Topaz in patients with significant tricuspid regurgitation (TR) who are not candidates for open-heart surgery. The trial aims to enroll approximately 80 patients and includes interim data analysis and long-term follow-up evaluations.

The first implantation of the Topaz valve was performed by interventional cardiologist Liesbeth Rosseel, MD, at Algemeen Stedelijk Ziekenhuis in Aalst, Belgium.

The female patient (age, 81 years) was experiencing torrential TR (grade 5 of 5), with a history of surgical interventions, along with typical comorbidities. The postintervention TR grade was reduced to zero, and the patient recovery to date has been positive, reported the company in the press release.

“I am pleased that the team here in Aalst performed the first implantation in the TRICURE EU pivotal study,” commented Dr. Rosseal in the TriCares press release. “The implantation was completed in approximately half an hour and reinforced the excellent outcomes that we previously observed in the TRICURE first-in-human study. We are encouraged by the patient's recovery to date and look forward to supporting the trial in the weeks and months ahead.”

Professor Joerg Hausleiter, MD, who is Professor of Medicine and the Deputy Clinic Director at the Ludwig-Maximilian University in Munich, Germany, added, “The TRICURE EU pivotal study is an important trial to prove that the Topaz valve can safely reduce, and even eliminate, TR in severely ill patients. I am honored to be the coordinating principal investigator of this critical study, contributing to an innovative solution for a large patient group urgently seeking an effective treatment option.”

The company advised that approximately 40 Topaz valve implantations have been performed across Europe and Canada. In the coming months, TriCares will begin patient enrollment in TRICURE EFS, the early feasibility study in the United States approved by the FDA earlier this year.