Findings Presented From Abbott TriClip TEER TRILUMINATE Pivotal Trial

June 7, 2024—Abbott announced the presentation of late-breaking data on the company’s TriClip transcatheter edge-to-edge repair (TEER) system for treatment of tricuspid regurgitation (TR).

The TRILUMINATE pivotal trial evaluated the device in a broad range of anatomies. Additionally, insights from an imaging substudy of the trial demonstrated the impact of TR on right heart remodeling.

The late-breaking data were presented at New York Valves 2024: The Structural Heart Summit held June 5-7 in New York, New York.

According to the company, the TRILUMINATE pivotal trial is primarily focused on evaluating the safety and effectiveness of the TriClip system in patients with TR. Investigators compared the procedural outcomes of tricuspid TEER to medical therapy alone across common anatomic subgroups to better establish protocols for different anatomies.

The findings showed that the TriClip continues to demonstrate a high safety profile, with an effective reduction in TR and improved quality of life across a broad range of anatomies, advised Abbott.

The imaging substudy was conducted on a subset of patients in the TRILUMINATE pivotal trial who agreed to undergo additional imaging to provide insights on TR reduction and cardiac reverse remodeling. Investigators used serial cardiac MRI and cardiac CT imaging.

According to Abbott, the results showed that multicentric high-quality cardiac CT and MRI of the right heart are possible in both patients with severe TR and patients with atrial fibrillation. Additionally, cardiac MRI confirmed a significant TR reduction after TriClip treatment.

Finally, TR reduction with TriClip was associated with reverse remodeling of the heart, with the magnitude of reverse remodeling associated with the extent of TR reduction.