CAESAREA, Israel, March 28,
2024 /PRNewswire/ -- V-Wave today announced it will
present late-breaking data from its RELIEVE-HF pivotal trial at the
American College of Cardiology's (ACC) Annual Scientific Session
& Expo taking place April 6-8 in
Atlanta. RELIEVE-HF is a
randomized, double-blind, placebo-procedure-controlled,
multicenter, multinational, pivotal trial of the
V-Wave® Ventura® Interatrial Shunt in
symptomatic patients with reduced (HFrEF) or preserved (HFpEF) left
ventricular ejection fraction at high risk of heart failure
(HF)-related events.
"We're pleased to present the RELIEVE-HF data at this year's ACC
meeting, as we continue to advance this important technology with
the goal of bringing a much-needed treatment option to patients
with advanced heart failure, a leading cause of death and
hospitalization in the U.S. and worldwide," said Neal Eigler, M.D., CEO of V-Wave.
Summary of Presentation
Abstract Title
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Primary Author
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Type/#
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Session Title
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Time (ET)
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Location
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Saturday, April 6, 2024
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A Double-blind,
Randomized, Placebo Procedure-controlled Trial of an Interatrial
Shunt in Patients with HFrEF and HFpEF: Principal Results From the
RELIEVE-HF Trial
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Stone, G.
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Late-Breaking Clinical
Trials (Session 402)
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402-08: Joint American
College of Cardiology/Journal of the American College of Cardiology
Late-Breaking Clinical Trials
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9:30-9:42 a.m.
ET
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Hall B-1 Main
Tent
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About RELIEVE-HF
The randomized, double-blind,
placebo-procedure-controlled, multicenter, multinational, pivotal
RELIEVE-HF clinical study (NCT03499236) evaluated the safety and
effectiveness of the investigational V-Wave®
Ventura® Interatrial Shunt for the treatment of HF. The
study enrolled 508 patients with advanced HF on maximally tolerated
guideline-directed medical therapy who were randomized 1:1 and
stratified by LVEF to either the V-Wave®
Ventura® Interatrial Shunt treatment arm or the control
arm, who received a placebo procedure (sham). Additional patients
were enrolled in an open-label (unblinded), roll-in arm, all of
whom received the V-Wave® Ventura®
Interatrial Shunt.
The primary effectiveness endpoint was a composite of death,
heart transplant/left ventricular assist device (LVAD)
implantation, HF hospitalization, outpatient HF worsening, and
quality of life. The primary safety endpoint was measured as
device-related and procedure-related major adverse cardiovascular
or neurological device-related events (MACNE) at 30 days. Patients
were followed for the primary analysis for a minimum of 12 months
and a maximum of 24 months (median of 22 months). The study was
performed under the U.S. Food and Drug Administration's
Breakthrough Devices Program and enrolled patients at 101 hospitals
in 11 countries, including in the U.S., Canada, Israel, Australia and New
Zealand.
About Heart Failure
Heart failure (HF) is a chronic,
progressive disease in which the heart cannot pump enough blood to
meet the body's needs. HF affects 7 million people in the U.S,
where it is a leading cause of death and
hospitalization,i and 56.2 million people globally.
When HF occurs, there is an increase in left atrial pressure, which
causes fluid to back up in the lungs. This causes pulmonary
congestion and makes it hard to breathe during activities or even
at rest. In addition to shortness of breath, symptoms include
general fatigue, tiredness, rapid weight gain due to fluid
retention, and swollen legs and feet.
There are two types of HF. HFpEF is HF with preserved ejection
fraction in which pressure builds up in the heart and lungs due to
a stiffened left ventricle. This type of HF is largely associated
with obesity and hypertension. In HFpEF, left ventricular ejection
fraction (LVEF, a measure of the heart's ability to pump
oxygen-rich blood to the body) is >40. HFrEF is HF with reduced
ejection fraction in which the left ventricle, the main pumping
chamber of the heart, is weakened and usually enlarged and can't
effectively pump oxygen-rich blood to the body. In HFrEF, LVEF is
<40.
Treatments for HF, which include medications, lifestyle changes
and medical devices, typically focus on improving survival,
reducing the risk of heart failure hospitalizations, and providing
symptom relief. Despite advances in HF therapy, premature death,
recurrent hospitalizations and deteriorating quality of life remain
a large burden to patients, their families and the U.S. healthcare
system.
About V-Wave
V-Wave is a privately held medical device
company that was established in 2009 and is focused on developing
innovative treatment options for people living with heart failure
and cardiovascular disease. The company was built on a foundation
of science, engineering and medicine and has decades of experience
in these fields. V-Wave's lead program is the investigational
V-Wave® Ventura® Interatrial Shunt, which has
Breakthrough Device Designation from the U.S. Food and Drug
Administration and is designed to offer a safe, minimally invasive
approach to treat heart failure. The company has offices in
Israel and the U.S. For more
information, please visit www.vwavemedical.com or V-Wave on
LinkedIn.
Forward-Looking Statement
This press release contains certain forward-looking statements that
involve risks and uncertainties, including statements related to
clinical development and potential regulatory approval of V-Wave's
products. All forward-looking statements and other information
included in this press release are based on information available
to V-Wave as of the date hereof, and the Company assumes no
obligation to update any such forward-looking statements or
information. The company's actual results could differ materially
from those described in the company's forward-looking
statements.
CAUTION, the V-Wave® Ventura® Interatrial
Shunt System is not available for sale in the United States or other countries. Limited
by Federal (or United States) law
to investigational use.
Contact
Elliot Fox,
Real Chemistry
efox@realchemistry.com
207-604-0956
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i https://hfsa.org/research/hf-stats
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SOURCE V-Wave Ltd.