Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement

Completed

Conditions studied: Aortic Stenosis

In brief

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.

Key facts

Study ID

NCT00584116

Run by

University of California, Davis

People needed

2

Starts

2006-03-01

Expected to finish

2008-03-01

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• UC Davis Medical Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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