Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00584116

Acronym

BAV-SAVR

Enrollment

Registered

2008-01-02

Start date

2006-03-31

Completion date

2008-03-31

Last updated

2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

Keywords

Aortic Valve Replacement, AVR

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
aortic annulus size	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)

Countries

United States

Outcome results