The TriClip transcatheter edge-to-edge repair (TEER) system offers an option for those who aren’t good candidates for surgery and continue to have symptoms or persistent tricuspid regurgitation (TR) despite treatment with medical therapy.
Delivered through a vein in the leg, the TriClip TEER technology clips together a portion of leaflets. It repairs the tricuspid valve and helps blood flow in the right direction without the need for open-heart surgery.
The system received FDA approval in April 2024. Abbott shared study findings earlier this year demonstrating the device’s safety and effectiveness.
Abbott’s TREAT TR study aims to evaluate the safety and performance of TriClip in a real-world setting. The company hopes to build on an existing body of evidence supporting the system’s benefits for TR.
Dr. Xavier Freixa and his team at Hospital Clínic de Barcelona completed the first enrollment in TREAT TR.
Abbott plans for the study to enroll approximately 1,000 people at up to 100 sites in the U.S., Canada and Europe. Investigators intend to follow patients for five years, checking in at discharge, 30 days, six months and one year, then once annually for the remaining four years. A sub-study will also evaluate the potential for TriClip to reverse cardiac remodeling. These changes to the structure of the heart occur as a result of injury or chronic overload.
Dr. Anita Asgar, section head of interventional cardiology and medical director for the Bluhm Cardiovascular Institute, Structural Heart Program at Northwestern Medicine in Chicago, and co-principal investigator of TREAT TR, said:
“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. 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.”
