Abbott has initiated a pivotal investigational device exemption (IDE) trial to evaluate the use of its TriClip transcatheter tricuspid valve repair system to treat severe tricuspid regurgitation (TR).
TR is the backward flow of blood into the heart due to improper closing of the tricuspid valve. Therapy options for this condition, which can result in heart failure, are currently limited.
TriClip offers a catheter-based, non-surgical treatment option.
The investigational system builds on the company’s commercially available MitraClip system, which is a transcatheter mitral valve treatment.
The IDE trial TRILUMINATE will assess the safety and effectiveness of the TriClip system compared to medical therapy. It will involve a follow-up period of five years.
The prospective, multi-centre, randomised, controlled trial will recruit around 700 patients at sites across the US, Europe and Canada. It will include a single arm for patients with more complex tricuspid valve disease.
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The first patient has been enrolled at Abbott Northwestern Hospital in Minneapolis, US.
Abbott structural heart business chief medical officer Neil Moat said: “While we’ve made substantial progress on a number of fronts for challenging structural heart conditions, tricuspid regurgitation impacts far too many patients worldwide and physicians are limited by a lack of meaningful therapy alternatives to surgery.
“Early results with our TriClip repair system have been encouraging and we’re excited to continue driving innovation that we believe will benefit more patients in the future.”
The TRILUMINATE IDE trial comes after TriClip showed a favourable profile in the smaller TRILUMINATE study, which was performed in the US and Europe to investigate the system’s safety and performance.
According to the study data, 86.6% of the participants treated with Abbott’s device experienced a decrease in TR severity of at least one grade after 30 days.
The system also demonstrated a good safety profile for the procedures in patients who were at high risk for surgery.
Furthermore, some patients saw an improvement in the heart failure symptoms measured with the New York Heart Association (NYHA) functional classification and the Kansas City Cardiomyopathy Questionnaire (KCCQ) score.
The TriClip device has also been accepted for national reimbursement consideration by the US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS).