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Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement (BAV-SAVR)

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ClinicalTrials.gov Identifier: NCT00584116
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Aortic Stenosis

Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement
Study Start Date : March 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. aortic annulus size [ Time Frame: 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient with severe symptomatic calcific aortic stenosis (AS) referred for elective surgical aortic valve replacement.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584116


Locations
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Jason Rogers, MD University of California, Davis

Additional Information:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00584116     History of Changes
Other Study ID Numbers: 200614760
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by University of California, Davis:
Aortic Valve Replacement
AVR

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction