This FIH trial of a novel Valvuloplasty Scoring Balloon will enroll 30 patients with symptomatic critical aortic valve stenosis
at the renowned trans-catheter aortic valve replacement (TAVR) program at St.
Senile aortic valve stenosis
is a progressive, age-related disease caused by calcium deposits on the aortic valve that cause the valve to narrow.
All of the patients undergoing AVR (n=33) had aortic valve stenosis
(AS) as the result of adult type calcific aortic valve stenosis
(CAS) and all of the patients with MVR (n=42) have been referred to surgery due to mitral valve stenosis (MS) secondary to rheumatic heart disease (RHD).
As a result of simulation, a remarkable increase of the left ventricle systolic blood pressure and aortic mean pressure gradient, and decrease of aortic systolic blood pressure are observed in severe aortic valve stenosis
These patients are currently not candidates for open heart surgery and TAVR provides a treatment option that simply was not available to patients with severe aortic valve stenosis
in the past.
REPRISE II is evaluating the Lotus Valve System in symptomatic patients with severe aortic valve stenosis
considered at high risk for surgical valve replacement.
31, 2013 /PRNewswire/ -- The Boston Scientific Corporation (NYSE: BSX) Lotus(TM) Valve System met a key performance measure in the treatment of symptomatic patients with severe aortic valve stenosis
considered at high risk for surgical valve replacement, according to new data released today at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco.
While it is true, that quadricuspid aortic valve stenosis
has been described (2), it is extremely rare.
Food and Drug Administration approved the SAPIEN Transcatheter Heart Valve for the treatment of patients with severe aortic valve stenosis
who have been determined by a cardiac surgeon to be inoperable for open-heart aortic valve replacement.
GlobalData's clinical trial report, Aortic Valve Stenosis
Global Clinical Trials Review, H2, 2011" provides data on the Aortic Valve Stenosis
clinical trial scenario.
In patients with aortic valve stenosis
, the self-expanding transaortic transcatheter aortic valve bioprosthesis implant, was associated with a significantly higher rate of survival after one year, than open heart surgical aortic valve replacement," states Brijeshwar Maini, MD, FACC, medical director of the PinnacleHealth Heart Valve Clinic.
With the number of aortic valve stenosis
patients steadily rising as the Japanese population ages, we consider this an important step towards the introduction of a new therapeutic option to the healthcare system," said Professor Sawa.
Martin Leon, Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York and chair of the study's Clinical Steering Committee, noted, "This study is designed to include patients with severe symptomatic calcified native aortic valve stenosis
who are candidates for undergoing TAVR.
This system is used to treat severe aortic valve stenosis
in elderly high-risk patients, especially in patients for whom conventional open-heart surgery is not an option.
Therefore like those with heart attacks, individuals with aortic valve stenosis
and their family members should have Lp(a) measured," said Professor, Chief Physician Borge Nordestgaard from Copenhagen University Hospital in Denmark.