Six-Month Data From TRILUMINATE Feasibility Study Presented for Abbott's TriClip Device

September 28, 2019—Abbott announced new data from the TRILUMINATE Feasibility Study were presented at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium, held September 25–29 in San Francisco, California.

The prospective, single-arm, multicenter study investigated the performance of Abbott’s clip-based repair technology using the investigational TriClip tricuspid valve repair system at 21 sites across the United States and Europe. The TriClip design is based on the company’s commercially available MitraClip technology.

According to the company, the 6-month TRILUMINATE Feasibility Study findings suggest that the TriClip device may be an effective minimally invasive repair option for patients with tricuspid regurgitation (TR). The data showed that treatment with TriClip in patients with moderate to severe TR was safe and associated with strong clinical improvement at 6-months.

The results presented at TCT 2019 included the following:

• 87% of patients treated with TriClip had a reduction in TR at 6 months, with 57% of patients implanted had a TR classification of moderate or better versus 6% of patients with the same classification at the time of enrollment.
• Symptom improvement with 87% of patients implanted with TriClip being classified as New York Heart Association functional class I/II at 6 months versus 25% of patients receiving the same classification at the time of enrollment.
• Patients receiving TriClip showed improved quality of life in Kansas City Cardiomyopathy Questionnaire scores and a reduction in symptoms that are associated with a reduced burden of their clinical condition and improved physical output.

According to Abbott, the 6-month results presented at TCT 2019 build upon the initial 30-day data from the TRILUMINATE Feasibility Study that were presented at the 2019 EuroPCR conference, which was held May 21–24 in Paris, France.

Georg Nickenig, MD, who is lead investigator of the study, commented in the company's announcement, "Since we enrolled our first patient in the study, we have seen promise in this device for effectively treating people with tricuspid regurgitation. The potential for a catheter-based option like Abbott’s TriClip device is promising for long-term patient outcomes, and we look forward to continuing to share additional findings in the future."