Research is at the heart of everything we do
Learn more about the AMEND TS Studies
The AMEND TS Studies are prospective studies designed to evaluate the safety and performance of surgical style repair of mitral valve delivered through a catheter in patients with significant mitral incompetence.
The studies aim to enroll and treat patients at several investigational sites in the United States and Europe, thereby generating clinical evidence across diverse populations. As single arm studies, all enrolled and accepted patients will be treated with the AMEND system.
AMEND TS Early Feasibility Study
Study Overview
AMEND TS Early Feasibility Study (EFS) will evaluate the AMEND Trans-Septal System as a surgical annuloplasty style repair in patients with significant functional mitral regurgitation. It is enrolling patients at several investigational sites in the United States.
Study Design
AMEND TS Early Feasibility Study (EFS) will evaluate the AMEND Trans-Septal System as a surgical annuloplasty style repair in patients with significant functional mitral regurgitation. It is enrolling patients at several investigational sites in the United States.
Patient Population Characteristics
Subjects with symptomatic functional mitral regurgitation that is anatomically amenable to transcatheter mitral annuloplasty.
Subjects will be studied for up to 5 years.
Endpoints
Both safety and performance endpoints will be assessed from procedure over the first year of the study.
Study Leadership
Study Chair
Dr. Scott Lim
Professor of Medicine & Pediatrics
Director – Advanced Cardiac Valve Center, Cardiovascular Division
University of Virginia School of Medicine
Charlottesville, VA, USA
Primary Investigators
Dr. Isaac George
Surgical Director, Structural Heart and Valve Center
Surgical Director, Structural Heart Disease at New York-
Presbyterian Hospital
Co-Director, Mitral and Tricuspid Center
Columbia University Medical Center/New York-Presbyterian
New York, NY, USA
Dr. Paul Sorajja
Professor of Medicine, Associate Director of the Banner Heart
Institute, Director of Interventional Cardiology and Structural Heart, and Lentsch Family Director of Structural Heart for Banner Cardiovascular service line
Banner University Medical Center
Phoenix, AZ, USA
AMEND TS Pilot Europe Study
Study Overview
The AMEND TS Pilot Study will evaluate the AMEND Trans-Septal System as a surgical annuloplasty style repair either alone or in combination with TEER in patients with significant functional mitral regurgitation in order to optimize outcomes. It is enrolling patients at investigational sites in Europe.
Study Design
A prospective, single-arm study to evaluate the AMEND Trans-Septal System as stand alone annuloplasty or in combination with TEER in patients for significant functional mitral regurgitation.
Patient Population Characteristics
Subjects with symptomatic functional mitral regurgitation that is anatomically amenable to transcatheter mitral annuloplasty.
Subjects will be studied for up to 1 year.
Endpoints
Both safety and performance endpoints will be assessed from procedure during the study duration.
Enrolling Centers
Primary Investigators
Dr. Bruno Melica
Cardiology Department
Centro Hospitalar de Vila Nova de Gaia/Espinho
Vila Nova de Gaia, Portugal
Dr. Sergio Berti
Unità Operativa Complessa
Cardiologia Diagnostica ed Interventistica
Ospedale del Cuore Gaetano Pasquinucci Fondazione
Gabriele Monasterio
Massa, Italy
Dr. Federico De Marco
Unità Operativa di Cardiologia Interventistica Valvolare e Strutturale
Centro Cardiologico Monzino IRCCS
Istituto di Ricovero e Cura a Carattere Scientifico
Milano, Italy
Dr. Elvis Brscic
Dipartimento Cardiaco e Emodinamica
Humanitas Gavazzeni
Bergamo, Italy
Dr. Fausto Castriota
Dipartimento Cardiovascolare
Maria Cecilia Hospital
Cotignola, Ravenna, Italy
Dr. Carmelo Grasso
UOC Cardiologia
Azienda Ospedaliera Universitaria Policlinico Gaspare
Rodolico-San Marco UOC Cardiologia
Catania CT, Italy
Dr. Francesco Bedogni
Unità Operativa di Cardiologia Ospedaliera, UTIC e Cardiologia Interventistica
IRCCS Policlinico San Donato
San Donato Milanese MI, Italy