Abbott has initiated the TREAT TR post-market study of the TriClip transcatheter edge-to-edge repair (TEER) system for the treatment of tricuspid regurgitation (TR).
The study is designed to evaluate the safety and performance of TriClip in a real-world setting and build on existing evidence concerning the safety and efficacy of the device in addressing TR. The first enrolment in the TREAT TR study occurred at Hospital Clínic de Barcelona (Barcelona, Spain), led by Xavier Freixa and his cardiac team.
The prospective study will enrol approximately 1,000 people at up to 100 sites in the USA, Canada and Europe. Patients will be followed for five years with check-ins at discharge, 30 days, six months and one year, and then once annually for the remaining four years.
A select group of patients will also be enrolled in a sub-study that will evaluate the potential for the TriClip system to reverse cardiac remodelling, which are changes in the structure of the heart that occur when it is injured or subjected to chronic overload.
“Prior to TriClip’s availability, many patients with tricuspid regurgitation had few treatment options because medical therapy didn’t relieve their symptoms or they were at an increased risk for conventional open-heart surgery,” said Anita Asgar (Northwestern Medicine, Chicago, USA), co-principal investigator of the TREAT TR study. “Through multiple clinical studies and in working directly with patients, we’ve seen that TriClip can have a profound impact on the lives of people with TR, and we’re excited to see additional evidence to support this minimally invasive device.”
TriClip has been evaluated in several studies, including the TRILUMINATE Pivotal trial, which showed the system safely and effectively reduced TR and heart failure hospitalisation while improving quality of life. The study supported US Food and Drug Administration (FDA) approval of the system.
Additional real-world data evaluating the TriClip system were presented at the 2026 New York Valves meeting (24–26 June, New York, USA). The study, which included 3,035 patients from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry across 278 US sites, demonstrated outcomes consistent with the TRILUMINATE Pivotal trial with patients achieving significant reduction in TR while improving their quality of life.
