News | Heart Valve Technology | June 11, 2019

Abbott Tricuspid Valve Repair System Reduces Tricuspid Regurgitation at 30 Days

Late-breaking data for Abbott's investigational clip-based tricuspid heart valve repair system presented at EuroPCR

Abbott Tricuspid Valve Repair System Reduces Tricuspid Regurgitation at 30 Days

June 11, 2019 — Abbott recently announced positive late-breaking data from its TRILUMINATE study of the company's minimally invasive tricuspid valve repair system. Results at 30 days demonstrated the investigational device is associated with a reduction of tricuspid regurgitation (TR) symptoms — caused by a leaky tricuspid heart valve — suggesting a possible treatment option for people suffering from this difficult-to-manage structural heart disease. Abbott's transcatheter tricuspid valve repair (TTVR) system builds on the continued advances of the company's clip-based MitraClip technology, which treats people with leaky mitral valves.

Results from the TRILUMINATE study were presented in a late-breaking trial session at EuroPCR, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), May 21-24 in Paris, France.  

"Treating a leaky tricuspid heart valve has long presented a significant challenge for cardiologists because it is an extremely complex and difficult heart valve to treat," said Georg Nickenig, M.D., Ph.D., professor and chief, Department of Cardiology, University Hospital, Bonn, Germany, and lead investigator of the study. "These data are extremely encouraging, and I am excited about the potential of transcatheter tricuspid valve repair as a minimally invasive treatment option for these very ill patients who have no other options."

Tricuspid regurgitation is a condition in which the valve between the two chambers on the right side of the heart does not close properly, resulting in a backward flow of blood into the right chamber of the heart, which can ultimately result in heart failure and death if left untreated.1, 2, 3 Approximately one in 30 people over the age of 65 in the U.S. alone have moderate or severe TR.4 Surgery is the only definitive treatment but is rarely performed due to the high mortality and morbidity rates associated with the procedure. Currently, there are no approved non-surgical, minimally invasive treatments for people with moderate or severe tricuspid regurgitation.

TRILUMINATE is a prospective, single arm, multi-center study at 21 sites in Europe and the United States. The study is evaluating the safety and performance of the tricuspid valve repair system in 85 patients with symptomatic moderate or greater tricuspid regurgitation who were determined to be good candidates for percutaneous transcatheter intervention. Results show that at 30 days:

  • Eighty-six-point-six (86.6) percent of patients saw a reduction in TR severity of at least one grade (p < 0.0001);
  • A significantly greater proportion of patients were categorized as NYHA class I or II (80.5 percent at 30 days, compared to 25.6 percent at baseline), an improvement that was statistically significant. Doctors use the New York Heart Association (NYHA) classification system (I-IV) to classify heart failure according to the severity of a person's symptoms, with class I causing little to no physical limitations and discomfort; and
  • Patients also experienced a mean improvement in KCCQ score — a self-assessment of social abilities, symptoms and quality of life — from 53.05 at baseline to 67.25 at 30 days, which was an increase of 14.20 points (a five-point increase is considered clinically significant).

Clinical follow-up will continue through six months and one, two and three years.  

Abbott's transcatheter tricuspid valve repair system is an investigational device only.

For more information:

Related TRILUMINATE Content

Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System

VIDEO: Transcatheter Tricuspid Valve Repair and Replacement Technologies

VIDEO: Tricuspid Device Clinical Trial Overview


1.  Singh J.P. , Evans J.C. , Levy D., et al . Prevalence and clinical determinants of mitral, tricuspid, and aortic regurgitation (the Framingham Heart Study). Am J Cardiol 1999;83:897–902.doi:10.1016/S0002-9149(98)01064-9.

2. Vassileva C.M. , Shabosky J., Boley T., et al . Tricuspid valve surgery: the past 10 years from the Nationwide Inpatient Sample (NIS) database. J Thorac Cardiovasc Surg 2012;143:1043–9.doi:10.1016/j.jtcvs.2011.07.004.

3. Stuge O., Liddicoat J. Emerging opportunities for cardiac surgeons within structural heart disease. J Thorac Cardiovasc Surg 2006;132:1258–61.doi:10.1016/j.jtcvs.2006.08.049.

4. Topilski Y. Tricuspid valve regurgitation: epidemiology and pathophysiology. Minerva Cardioangiologica 2018 Mar 28 DOI: 10.23736/S0026-4725.18.04670-4).

Related Content

Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
Overlay Init