TRILUMINATE Trial Begins for Abbott Vascular's Transcatheter Tricuspid Valve Repair System
August 11, 2017—Abbott Vascular announced that the first patient has been enrolled in the TRILUMINATE clinical study to evaluate the company's clip-based transcatheter tricuspid valve repair (TTVR) system for treating patients with moderate or severe tricuspid regurgitation. The TTVR system builds on the company's MitraClip system, which has shown to predictably and effectively treat mitral regurgitation. TRILUMINATE is expected to support Abbott Vascular's application for CE Mark approval of the device in Europe.
The prospective, single-arm, multicenter study is designed to evaluate the performance of the TTVR clip-based technology in approximately 75 symptomatic patients at 25 sites in the United States and Europe. The primary endpoints are an echocardiographic tricuspid regurgitation reduction of ≥ 1 grade at 30 days after the procedure and the assessment of major adverse events at 6 months.
The first patient was enrolled by Paul Sorajja, MD, at Abbott Northwestern Hospital in Minneapolis, Minnesota. The study's Lead Investigator is Georg Nickenig, MD, Professor and Chief, Department of Cardiology, University Hospital, Bonn, Germany.
In the company's announcement, Prof. Nickenig commented, "Current pharmacological and surgical treatment options are not meeting the needs of people living with tricuspid regurgitation. Abbott's MitraClip has shown positive results for mitral regurgitation, and we hope this study shows that a similar clip-based technology may effectively treat people with tricuspid regurgitation."