Brief Title
Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement
Official Title
Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement
Brief Summary
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.
Study Type
Observational
Primary Outcome
aortic annulus size
Condition
Aortic Stenosis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
2
Start Date
March 2006
Completion Date
March 2008
Primary Completion Date
March 2008
Eligibility Criteria
Inclusion Criteria: - 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 Exclusion Criteria: - 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jason Rogers, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00584116
Organization ID
200614760
Responsible Party
Sponsor
Study Sponsor
University of California, Davis
Study Sponsor
Jason Rogers, MD, Principal Investigator, University of California, Davis
Verification Date
May 2017