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OpenTrials
Completed

NCT Number: NCT00584116

Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Acronym: BAV-SAVR

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 2, 2008
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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