NCT00535899

Brief Summary

In patients with aortic stenosis and low ejection fraction, how can we predict who will recover their ejection fraction after aortic valve replacement? We plan to observe 50 patients with Low EF aortic stenosis and perform serial echocardiograms pre and post-aortic valve replacement and analyze regional wall motion contractility with a new software application called speckle tracking imaging.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
Last Updated

May 26, 2008

Status Verified

May 1, 2008

First QC Date

September 25, 2007

Last Update Submit

May 22, 2008

Conditions

Aortic Stenosis

Keywords

Aortic stenosisSpeckle tracking imagingLow ejection fractionAortic valve replacementStrain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe aortic stenosis with ejection fraction less than 40% that is schedule to undergo aortic valve replacement

You may not qualify if:

  • Creatinine \> 2
  • More than moderate mitral, tricuspid, or aortic regurgitation.
  • Endocarditis
  • Emergent surgery
  • Prior sternotimy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Aortic Valve StenosisSprains and Strains

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionWounds and Injuries

Study Officials

  • Ryan P Daly, MD

    CCF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 25, 2007

First Posted

September 26, 2007

Study Start

September 1, 2007

Last Updated

May 26, 2008

Record last verified: 2008-05

Locations

US(1)