News | Structural Heart | May 19, 2023

New Late-breaking Data Reinforce the Benefits of Abbott's TriClip Device for People with Tricuspid Valve Disease

Data presented at EuroPCR 2023 builds on prior study results demonstrating TriClip is a safe and effective therapy to treat leaky tricuspid valves

Data presented at EuroPCR 2023 build on prior study results demonstrating TriClip is a safe and effective therapy to treat leaky tricuspid valves

May 19, 2023 — Abbott announced late-breaking data that add to the body of clinical evidence supporting the benefits of the TriClip transcatheter edge-to-edge repair (TEER) system in treating patients with leaky tricuspid valves. Abbott's TriClip device is a first-of-its kind, minimally invasive device designed specifically for tricuspid heart valve repair.

The results were presented at EuroPCR, the annual meeting of the European Association of the Percutaneous Cardiovascular Interventions, held in Paris from May 16-19, 2023.  

30-Day Outcomes From the TriClip bRIGHT Study

The results of the bRIGHT study, the largest real-world dataset for transcatheter tricuspid valve repair, support the safety and effectiveness of the TriClip system in patients with tricuspid regurgitation (TR). Outcomes from 511 patients in 26 sites across Europe for this prospective, multi-center, single-arm post-market study were presented for the first time at EuroPCR 2023.

Key findings through 30 days include:

  • Significant TR reduction. Repair with the TriClip system resulted in reduction of TR grade to moderate or less for 77% of the patients.
  • Significant clinical and quality of life improvements. 79% of participants achieved New York Heart Association (NYHA) Functional Class I/II (meaning they reached a point of slight or no limitation of physical activity), a nearly 60% improvement from the baseline proportion of 20%. In addition, more than half (56%) of patients reported a 15-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (a self-assessment of symptoms, physical and social limitations, and quality of life), representing a substantial improvement in quality of life and health status.
  • A strong safety profile. Only 2.5% of patients who received the device experienced a major adverse event, a composite of cardiovascular death, heart attack, stroke, new onset of kidney failure and surgery for device-related adverse events.

"Many patients currently undergoing tricuspid TEER are at an advanced stage of the TR disease and experience severe symptoms, impacting their overall health and well-being," said Philipp Lurz, M.D., Ph.D., professor and deputy head of cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany. "Building strong clinical evidence around the value of a procedure like tricuspid valve repair is critical, and the real-world outcomes of the bRIGHT study reinforce the safety and effectiveness of TriClip in reducing TR and improving quality of life."

"Just as we lead the way for treating mitral regurgitation with our MitraClip device, we're excited about the opportunity to continue our track record of innovation to treat tricuspid regurgitation with our TriClip therapy," said Michael Dale, senior vice president of Abbott's structural heart business. "TriClip has already helped thousands of people in Europe since its introduction in 2020. As we work to make TriClip accessible to more people around the world, the latest data presented at EuroPCR are further proof that the therapy helps patients who have limited treatment options get back to living fuller, healthier lives."

TriClip is approved for use in more than 50 countries, including in Europe and Canada, and is an investigational device in the U.S.

For more information:

Find more EUROPCR23 content here 

Related Transcatheter Tricuspid Valve Repair Content:

Transcatheter Tricuspid Valve Repair Clip Device Cleared in Europe

Edwards Pascal Tricuspid Valve Transcatheter Repair System Approved in Europe

First Human Use of Transcatheter Duo Tricuspid Valve Announced in Ireland

VIDEO: Tricuspid Valve Imaging and Interventions Developing Hand-in-hand — Interview with Rebecca Hahn, M.D.

Advances in Transcatheter Tricuspid Valve Technologies

VIDEO: Tricuspid Device Clinical Trial Overview — Interview with Ori Ben-Yehuda, M.D.

8 Cardiovascular Technologies to Watch in 2020

TriClip Device For Tricuspid Regurgitation Effective at One Year in TRILUMINATE Study

Related MitraClip, Triclip, Amulet and Portico Content: 

MitraClip Reduces Mortality for Heart Failure Patients With Secondary Mitral Regurgitation 

VIDEO: MitraClip to Treat Heart Failure - Results of the COAPT Trial — Interview with William Abraham, M.D., 

VIDEO: Echocardiographic Findings in the COAPT Trial — Interview with Federico Asch, M.D. 

FDA Approves MitraClip for Use in Heart Failure Patients With Functional Mitral Regurgitation   

VIDEO: Impact of the COAPT Trial on Heart Failure Patients With Functional Mitral Regurgitation — Interview with Andreas Brieke, M.D. 

Transcatheter Mitral Valve Repair is Cost-Effective in Heart Failure Patients 

TAVR Expected to See Rapid Growth in Next 5 years 

FDA Clears Abbott Amplatzer Amulet LAA Occluder to Reduce Stroke in People With Atrial Fibrillation 

Portico TAVR System Found Safe and Effective for High-Risk Surgical Patients 

Portico TAVR System Reduces Severe Aortic Stenosis at 30 Days in Real-World Setting 

VIDEO: Comparison Between Watchman vs. Amulet LAA Occluders

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