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Clinical Trials/NCT02023060
NCT02023060
Recruiting
Not Applicable

Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation

Sheba Medical Center5 sites in 1 country100 target enrollmentNovember 2013
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ConditionsTrans Catheter Aortic ValveAortic Stenosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trans Catheter Aortic Valve
Sponsor
Sheba Medical Center
Enrollment
100
Locations
5
Primary Endpoint
Clinical outcome of patients undergoing transcatheter valve replacement
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The objective is to observe trends in patient characteristics and outcomes after aortic or mitral transcatheter heart valve replacement over time.

Detailed Description

To observe trends in patient characteristics and outcomes after aortic or mitral transcatheter heart valve replacement over time.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
November 2030
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Subject selected for transcatheter heart valve replacement
  • •Signed informed consent to participate in the study

Exclusion Criteria

  • •Inability to sign written informed consent.
  • •Pregnancy or breast feeding (women of childbearing potential will have a serum or urine pregnancy test).

Outcomes

Primary Outcomes

Clinical outcome of patients undergoing transcatheter valve replacement

Time Frame: 12 months

Mortality, change in New York Heart Association class, change in ejection fraction.

Study Sites (5)

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