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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jason Rogers, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00584116
First received: December 26, 2007
Last updated: January 31, 2014
Last verified: January 2014
  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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Jason Rogers, MD, Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT00584116     History of Changes
Other Study ID Numbers: 200614760
Study First Received: December 26, 2007
Last Updated: January 31, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014