News | Heart Valve Technology | September 05, 2017

Minneapolis Heart Institute Foundation Enrolls First Patient in TRILUMINATE Tricuspid Repair Trial

Prospective, single-arm, multi-center study will assess clip-based system for tricuspid regurgitation repair in approximately 75 asymptomatic patients at 25 sites across the U.S. and Europe

Minneapolis Heart Institute Foundation Enrolls First Patient in TRILUMINATE Tricuspid Repair Trial

September 5, 2017 — Minneapolis Heart Institute Foundation announced it has enrolled the first-in-the-world patient in a clinical study to evaluate a minimally invasive clip-based repair system made by Abbott for treating people with moderate or severe tricuspid regurgitation (TR). This study is the first application of this minimally invasive technology for use in the tricuspid heart valve, where currently there are no options for most patients. Paul Sorajja, M.D., performed this first-in-human procedure at Minneapolis Heart Institute at Abbott Northwestern Hospital.

Tricuspid regurgitation is leakage of blood backwards into the right atrium through the tricuspid valve each time the right ventricle contracts. The increased volume of blood in the right atrium can cause it to enlarge, which can change the pressure in the nearby chambers and blood vessels. Currently there are no commercially available minimally invasive treatment options for people with moderate or severe TR and these patients face a poor prognosis.

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.

“Patients who have tricuspid regurgitation have limited options for treatment. Current guidelines recommend medical therapies or invasive surgical options to treat this disease,” said Sorajja, director of the MHIF Valve Science Center and investigator in the TRILUMINATE study. “Since less invasive approaches are currently unavailable to treat TR, patients who meet these study criteria and are enrolled will have access to this innovative technology. The opportunity for MHIF to provide the first-in-the-world implant is unprecedented. The core mission of MHIF’s Valve Science Center is to improve the health of patients with valvular heart disease through clinical research, innovation and education. Through a multidisciplinary approach, MHIF continues to provide first-in-human trials that improve patient options and change cardiology care worldwide.”

Read the article "Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System"

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.mplsheart.org


Related Content

News | Cardiovascular Clinical Studies

January 26, 2023 — A newly-released study extends the understanding of how acquired mutations in blood cells act as a ...

Home January 26, 2023
Home
News | Cardiovascular Clinical Studies

January 24, 2023 — Four cardiology organizations have joined forces in a call to action to reinvent randomized clinical ...

Home January 24, 2023
Home
News | Cardiovascular Clinical Studies

January 11, 2023 — Imbria Pharmaceuticals, Inc., a clinical stage, cardiometabolic company developing novel therapies ...

Home January 11, 2023
Home
News | Cardiovascular Clinical Studies

January 3, 2023 — Acutus Medical, Inc., an arrhythmia management company focused on improving the way cardiac ...

Home January 03, 2023
Home
News | Cardiovascular Clinical Studies

December 30, 2022 — The Cardiovascular Research Foundation (CRF) recently announced that Alexandra Popma, MD, has joined ...

Home December 30, 2022
Home
News | Cardiovascular Clinical Studies

December 28 2022 — Abiomed announces the United States Food and Drug Administration (FDA) has approved the version of ...

Home December 28, 2022
Home
News | Cardiovascular Clinical Studies

December 27, 2022 — A groundbreaking new clinical trial to determine the effectiveness of a new treatment for patients ...

Home December 27, 2022
Home
News | Cardiovascular Clinical Studies

December 21, 2022 — Esperion announced that the landmark Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting ...

Home December 21, 2022
Home
News | Cardiovascular Clinical Studies

December 13, 2022 — A new study by researchers at Intermountain Healthcare in Salt Lake City finds that patients without ...

Home December 13, 2022
Home
News | Cardiovascular Clinical Studies

December 9, 2022 — BioSig Technologies, Inc. an advanced digital signal processing technology company delivering ...

Home December 09, 2022
Home
Subscribe Now