Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement

University of California, Davis2 enrolled

Overview

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

Enrollment

Conditions

Aortic Stenosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

UC Davis Medical Center

Sacramento, California, United States

Outcomes

Primary Outcomes

aortic annulus size

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)

Time frame: 2 months

Data from ClinicalTrials.gov

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