Minneapolis Heart Institute Foundation® (MHIF) presented at the European Society of Cardiology (ESC) Congress the first outcomes from the TRILUMINATE Pivotal clinical trial, which is the first randomized, controlled trial to evaluate Abbott's TriClip™ system, a catheter-based, non-surgical treatment for patients with severe tricuspid regurgitation. Paul Sorajja, MD, Roger L. and Lynn C. Headrick Chair for the MHIF Valve Science Center and national principal investigator for the TRILUMINATE Pivotal trial, presented the data in a late-breaking, scientific session in Barcelona.
“We are proud to be a contributor to the clinical program for this minimally invasive technology that is the first with pivotal data showing promise in advancing outcomes for patients living with debilitating valve disease affecting the tricuspid heart valve,” said Dr. Sorajja. “For a long time, the tricuspid valve was thought of as the most difficult valve to treat because of its location in the heart. We’ve made great strides in the delivery and outcomes using the TriClip technology that can address disease in this valve that can lead to heart failure.”
Based on the analysis of the roll-in cohort treated as part of TRILUMINATE Pivotal, the early experience indicates the TriClip system may be effective and safe for patients with severe tricuspid regurgitation (TR). TRILUMINATE Pivotal is the first randomized, controlled clinical trial to evaluate the effectiveness and safety of transcatheter edge-to-edge repair (TEER) in patients with severe TR. The present analysis reports on the acute and 30-day clinical experience for the roll-in patients. Safety events were adjudicated by an independent review committee, with echo parameters assessed by an echo core lab. Additional highlights shared in the presentation:
- High implant success rate (99%)
- At least a one-grade TR reduction in 91% of patients, with moderate or less residual TR achieved in 74%
- Patients achieved around a 17-point average improvement in the KCCQ score (a self-assessment of social abilities, symptoms and quality of life)
The TriClip tricuspid valve repair system is manufactured by Abbott and built on the MitraClip™ system, a proven technology that is widely used for the treatment of mitral valve regurgitation. MHIF is a leader in research to advance treatments for heart valve disease and was also involved in studies that were used to gain regulatory approval for the MitraClip system.
In the U.S. alone, approximately one in 30 people over the age of 65 have moderate to severe tricuspid regurgitation.[i] Despite the prevalence of tricuspid valve disease, the tricuspid valve is often referred to as the "forgotten heart valve" as treatment options are limited. There are currently no approved non-surgical, minimally invasive treatments for people with severe tricuspid regurgitation in the U.S., which is why TriClip represents an important potential option for patients.
The TRILUMINATE Pivotal study is a prospective, multi-center, randomized, controlled global study of 700 patients enrolled in the United States, Canada and Europe. Patients were randomized to receive either the TriClip device or medical therapy and will be followed for a total of five years. The late-breaking presentation of data at ESC is the first release of clinical outcomes from the landmark pivotal trial that will be the basis of U.S. regulatory approval for the technology.
About the MHIF Valve Science Center
The Minneapolis Heart Institute Foundation® (MHIF) leads the world in minimally invasive, heart valve repair and replacement. These technologies repair and replace diseased heart valves - aortic, mitral, pulmonary, and tricuspid – through peripheral vessels or small incisions. The early recovery allows most patients to go home the day after the procedure and quickly resume their lives. The MHIF Valve Science Center is a multidisciplinary team of world-renowned physicians across multiple specialties, including interventional cardiologists, advanced imaging specialists, specialty nurses, research scholars and cardiac surgeons.
TriClip™ and MitraClip™ are trademarks of Abbott.
[i] Topilski Y. Tricuspid valve regurgitation: epidemiology and pathophysiology. Minerva Cardioangiologica 2018 Mar 28 DOI: 10.23736/S0026-4725.18.04670-4).