BioVentrix Announces Ralph Stephan von Bardeleben, MD, as Co- Principal Investigator of the REVIVE-HF Clinical Trial
03 März 2020 - 2:00PM
Business Wire
REVIVE-HF seeks to demonstrate superiority of the Revivent TC
System to current guideline treatment for heart failure
BioVentrix, Inc., developer of the first transcatheter device
for left ventricular remodeling after a heart attack, today
announced that Ralph Stephan von Bardeleben, MD, of the University
Medical Center of Mainz (Germany) has joined the European REVIVE-HF
clinical trial of the Revivent TC™ Transcatheter Ventricular
Enhancement System as co-principal investigator.
Dr. von Bardeleben heads the Heart Valve Center and Center of
Cardiology at the University of Mainz. He is an internationally
recognized authority in interventional cardiology leading a
specialized center for advanced transcatheter treatment concepts.
He joins co-principal investigators Stefan Anker, MD, of the
Berlin-Brandenburger Center for Regenerative Therapy (BCRT) and
Volkmar Falk, MD, Medical Director and Director of the Department
of Cardiothoracic Vascular Surgery at the German Heart Center,
Berlin.
“I am enthusiastic about joining the investigation of this new
approach providing a much-needed alternative to current
guideline-directed medical therapy for ischemic heart failure,” Dr.
von Bardeleben said. “As with catheter-based mitral valve
interventions, which created an effective option for thousands of
patients who could not undergo surgery, the Revivent TC System
offers the hope of effective restoration of left ventricular
function to many more patients without open surgery.”
REVIVE-HF is a prospective, multi-center, dual arm randomized
controlled study being conducted in Europe comparing the treatment
of ischemic cardiomyopathy-induced heart failure with the Revivent
TC System to Guideline-Directed Medical Therapy (GDMT). The study
encompasses 180 patients in a 2:1 study, comparing 120 patients
treated with the investigational therapy with 60 patients in a
control group treated with standard medical treatment alone.
Endpoints include improvement in exercise capacity and quality of
life as clinical functional parameters.
“Dr. von Bardeleben is a leader in less invasive catheter-based
heart valve therapy,” Dr. Anker said. “We are pleased to add Dr.
von Bardeleben as co-principal investigator of the REVIVE-HF
clinical trial and feel his expertise in less invasive cardiac
interventions will provide great value to the study.”
The first patient was enrolled and treated in the REVIVE-HF
study in September 2019.
The company also recently announced that Gregg Stone, MD,
director of academic affairs for the Mount Sinai Heart Health
System and co-director at the Cardiovascular Research Foundation in
New York City, NY, joined the U.S. pivotal trial of the Revivent TC
system – the ALIVE Trial - as a co-principal investigator. Dr.
Stone is considered a global expert on transcatheter cardiovascular
devices and has served as a principal investigator for more than
100 randomized trials.
Less Invasive Ventricular Enhancement, or the LIVE™ Therapy,
uses the Revivent TC System to exclude scar tissue on the left
ventricle that has occurred from a heart attack so the healthy
portion of the heart can operate more efficiently. Micro-anchors
are implanted and designed to remodel the heart to a more normal
shape and size and reduce wall stress, which has been shown to
improve blood flow throughout the body.
About BioVentrix
BioVentrix is a privately held medical device company
headquartered in San Ramon, CA, USA. Its mission is to improve and
expand the treatments available for congestive heart failure (CHF)
caused by ischemic cardiomyopathy through the development of less
invasive, catheter-based approaches.
Note: The Revivent TC™ System has received the CE Mark and is
approved for sale in Europe. It is considered investigational and
is not approved for sale in the United States.
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