Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement (BAV-SAVR)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
Prospective, two academic center, non-randomized pilot, acute in-patient study correlating pre-operative imaging studies, intra-operative measurements and intra-operative balloon aortic valvuloplasty (BAV) in patients with degenerative aortic stenosis undergoing surgical aortic valve replacement (SAVR) to understand the requirements (device size and radial strength) of emerging percutaneous heart valve technologies in the treatment of aortic stenosis.
Show the correlation between the size of the aortic annulus measured intra-operatively with surgical rings (gold standard) with other methods of aortic annulus measurement that would not require surgical intervention (CT, TEE, TTE)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Any patient with severe symptomatic calcific aortic stenosis (AS) referred for elective surgical aortic valve replacement.
Age 18 years or older
Any patient with severe, symptomatic calcific aortic stenosis (AS) referred for elective surgical aortic valve replacement.
Severe AS: aortic valve area (AVA) ≤ 1.0 cm2
Symptoms: dyspnea on exertion, heart failure, angina or syncope believed to be secondary to AS
Emergent surgical aortic valve replacement.
Inability to undergo TTE or TEE intra-operatively.
Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.