Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement

Completed

• Conditions: Aortic Stenosis

• Registration Number: NCT00584116
• Lead Sponsor: University of California, Davis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2008-01-02
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
aortic annulus size	2 months	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)

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States