News | Heart Valve Technology | August 09, 2017

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

First trial of its kind to evaluate minimally invasive treatment using clip technology for moderate or severe tricuspid regurgitation

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

August 9, 2017 — Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-based repair system for treating people with moderate or severe tricuspid regurgitation (TR). The first patient was enrolled at Abbott Northwestern Hospital by Paul Sorajja, M.D., cardiologist at Minneapolis Heart Institute and Abbott Northwestern Hospital.

The transcatheter tricuspid valve repair (TTVR) system builds upon Abbott's MitraClip System, which has shown to predictably and effectively treat mitral regurgitation, a similar disease impacting the left side of the heart.

Tricuspid regurgitation is a condition in which the valve between the heart's two chambers on the right side does not close properly, resulting in a backward flow of blood into the right atrium. The consequences of leaving it untreated can be substantial – people often develop other conditions such as atrial fibrillation, heart failure and, ultimately, death. Currently, there are no approved minimally invasive treatments for people with moderate or severe tricuspid regurgitation.

"Current pharmacological and surgical treatment options are not meeting the needs of people living with tricuspid regurgitation," said Georg Nickenig, M.D., Ph.D., professor and chief, Department of Cardiology, University Hospital, Bonn, Germany, and lead investigator of the study. "Abbott's MitraClip has shown positive results for mitral regurgitation, and we hope this study shows that a similar clip-based technology may effectively treat people with tricuspid regurgitation."

The clinical trial is expected to support Abbott's application for CE Mark in Europe for a clip-based transcatheter tricuspid valve repair system.

The study, called TRILUMINATE, is a prospective, single-arm, multi-center study designed to evaluate the performance of clip-based technology in approximately 75 symptomatic patients at 25 sites across the United States and Europe. The primary endpoints are an echocardiographic tricuspid regurgitation reduction of ≥ 1 grade at 30 days post-procedure, and the assessment of major adverse events at six months.

Read the article "Minneapolis Heart Institute Foundation Enrolls First Patient in TRILUMINATE Tricuspid Repair Trial."

Watch the VIDEO "Transcatheter Tricuspid Valve Repair and Replacement Technologies," an interview with Rebecca Hahn, M.D., FASE, at ASE 2017.

For more information: www.mitraclip.com

Related Content

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
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init