NCT00584116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

December 26, 2007

Last Update Submit

May 25, 2017

Conditions

Aortic Stenosis

Keywords

Aortic Valve ReplacementAVR

Outcome Measures

Primary Outcomes (1)

  • aortic annulus size

    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)

    2 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient with severe symptomatic calcific aortic stenosis (AS) referred for elective surgical aortic valve replacement.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Links

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Jason Rogers, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 2, 2008

Study Start

March 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(1)