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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584116
First Posted: January 2, 2008
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, Davis
  Purpose
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
Aortic Stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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)


Enrollment: 2
Study Start Date: March 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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
  More Information

Additional Information:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00584116     History of Changes
Other Study ID Numbers: 200614760
First Submitted: December 26, 2007
First Posted: January 2, 2008
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