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NCT00584116 Clinical Trial

Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement

Aortic Stenosis Clinical Trial

— BAV-SAVR  

Official title:
Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00584116
Other study ID # 200614760
Secondary ID
Status Completed
Phase N/A
First received December 26, 2007
Last updated May 25, 2017
Start date March 2006
Est. completion date March 2008

Study information
Verified date May 2017
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States UC Davis Medical Center Sacramento California

Sponsors (1)
Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) 2 months
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