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Clinical Trial Update: TRILUMINATE Launches to Rescue "Forgotten" Tricuspid Valve

Written By: Adam Pick, Patient Advocate, Author & Website Founder
Published: September 9, 2019

Big, big, big news!

Earlier today, Abbott announced the launch of the world's first pivotal clinical trial for the catheter-based treatment of tricuspid valve regurgitation. The trial, which is called TRILUMINATE, will evaluate the safety and effectiveness of the TriClip transcatheter valve repair system for leaky tricuspid valves. The TriClip does not require an incision to the patient's sternum or ribs.

TriClip Transcatheter Tricuspid Valve Repair System

As we previously discussed, the tricuspid valve is often referred to as the "forgotten heart valve". While the number of tricuspid valve procedures has increased during the past 15 years, the number of therapeutic options remain limited. According to TCTMD, there are currently no approved non-surgical, minimally-invasive treatments for patients with severe tricuspid regurgitation.

A Big Deal for Tricuspid Valve Patients!

The reason this is such a big deal for patients is that approximately one in thirty people over the age of 65 have moderate or severe tricuspid regurgitation. So, this is a very common form of heart disease that impacts millions of patients on a worldwide basis.

But... What makes the situation worse is that patients with severe tricuspid regurgitation are often NOT referred for therapy due to risk.

Dr. David Adams

Specific to this point, Dr. David Adams, a leading heart valve surgeon at The Mount Sinai Hospital, recently noted, "Patients with symptomatic tricuspid regurgitation are often at an increased risk for conventional surgery. As a result, many [patients] are not referred for intervention."

That said, the opportunity for a device - like the TriClip - to help these patients could be significant if the new technology is proven safe and effective.

For that reason, the TRILUMINATE Pivotal trial will enroll approximately 700 patients at cardiac centers across the United States, Canada and Europe. Like many other clinical trials, patients in the research study will be "randomized" to evaluate TriClip performance. That means 50% of enrolled patients will receive the TriClip and 50% of patients will receive medical therapy (the current standard of care).

Abbott's TriClip Valve Repair Device

Interestingly, the TriClip was built using Abbott's MitraClip system for the treatment of severe mitral regurgitation. The MitraClip has been commercially available in the United States since 2013 and has treated over 80,000 patients worldwide. Many patients in our community have seen wonderful results with the MitraClip including Michelle Golden and Phil Yalowitz, my uncle.

Congratulations to Abbott and the cardiac centers who have begun their research on the TRILUMINATE Pivotal clinical trial!

Written by Adam Pick - Patient & Website Founder

Adam Pick is a heart valve patient and author of The Patient's Guide To Heart Valve Surgery. In 2006, Adam founded HeartValveSurgery.com to educate and empower patients. This award-winning website has helped over 10 million people fight heart valve disease. Adam has been featured by the American Heart Association and Medical News Today.

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