ABBOTT PARK, Ill.
Prospective post-market study will enroll approximately 1,000 patients across the United States, Canada and Europe
TriClip provides a minimally invasive treatment option for eligible patients with symptomatic tricuspid regurgitation who face increased surgical risk
Abbott (NYSE: ABT) today announced the initiation of the TREAT TR study, a prospective post-market study evaluating the safety, performance and clinical outcomes of the company’s TriClip™ transcatheter edge-to-edge repair system in real-world clinical practice.
TriClip is specifically designed to treat tricuspid regurgitation, or TR, a condition commonly known as a leaky tricuspid heart valve. The TREAT TR study will expand the body of clinical evidence supporting the system and assess its performance across a diverse population of patients, healthcare centers and geographic regions.
The first patient in the study was enrolled at Hospital Clínic de Barcelona in Spain by Xavier Freixa, M.D., and his cardiac team.
Study to Enroll Approximately 1,000 Patients
The prospective, observational, single-arm, multicenter study is expected to enroll approximately 1,000 patients at as many as 100 clinical sites in the United States, Canada and Europe.
Participants will be evaluated at hospital discharge, 30 days, six months and one year following treatment. Annual follow-up assessments will then continue for an additional four years, providing five years of clinical information for each participating patient.
A selected group of patients will also participate in a sub-study examining whether treatment with TriClip may reverse cardiac remodeling—the structural changes that can occur when the heart is injured or subjected to prolonged pressure or volume 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, M.D., 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 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.”
Addressing Tricuspid Regurgitation
The tricuspid valve controls blood flow from the heart’s right atrium to its right ventricle. Tricuspid regurgitation occurs when the valve does not close properly, allowing blood to flow backward through the valve.
The condition can force the heart to work harder and may cause symptoms including fatigue, swelling and shortness of breath. When left untreated, severe TR may contribute to complications such as atrial fibrillation and heart failure.
TriClip is intended to provide an additional treatment option for eligible patients who remain symptomatic despite medical therapy and are considered to be at elevated risk for conventional open-heart surgery.
The system’s transcatheter edge-to-edge repair technology is delivered through a vein in the leg. It works by clipping together portions of the tricuspid valve leaflets, helping the valve close more effectively and reducing backward blood flow without requiring open-heart surgery.
Patients treated with TriClip spend an average of approximately one day in the hospital following the procedure before returning home.
Clinical Evidence Supports TriClip Treatment
TriClip has been evaluated through several clinical studies, including the TRILUMINATE Pivotal trial. Results from the trial demonstrated that the system reduced the severity of tricuspid regurgitation, improved patients’ quality of life and supported reductions in heart-failure-related hospitalizations.
Findings from the TRILUMINATE Pivotal trial supported approval of the TriClip system by the U.S. Food and Drug Administration.
Additional real-world evidence was presented in June 2026 at the New York Valves conference. The analysis included 3,035 patients recorded in the Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry across 278 clinical sites in the United States.
The registry findings showed outcomes consistent with those observed in the TRILUMINATE Pivotal trial, including meaningful reductions in TR severity and improvements in patients’ quality of life.
“Clinical studies have continued to reinforce the benefits of repairing the tricuspid valve with TriClip and the significant improvements that it brings to people’s daily lives, including reducing the rate of hospitalizations due to heart failure,” said Lars Sondergaard, M.D., chief medical officer of Abbott’s structural heart business.
“We believe the TREAT TR study will further confirm TriClip’s safety profile and effectiveness in reducing tricuspid regurgitation across a diverse range of patients and locations.”
About the TREAT TR Study
TREAT TR is a prospective, observational, single-arm, multicenter post-market study designed to evaluate the safety and real-world performance of the TriClip system.
The study will build upon existing clinical evidence and assess patient outcomes across a broader range of clinical environments, populations and geographic locations.
About TriClip™
TriClip is a minimally invasive treatment option designed to repair the tricuspid valve through transcatheter edge-to-edge repair.
The system has been approved for use in more than 50 countries, including the United States, Canada and countries across Europe, since receiving its initial CE Mark approval in 2020. TriClip has been used to treat more than 15,000 people with tricuspid regurgitation.
For important U.S. safety information regarding TriClip, visit:
About Abbott
Abbott (NYSE: ABT) is a global healthcare company that develops technologies designed to help people live more fully throughout all stages of life.
The company’s portfolio includes products and services across diagnostics, medical devices, nutrition and branded generic medicines. Abbott employs approximately 122,000 people and serves customers in more than 160 countries.
For additional information, visit Abbott.com.
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