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NCT Number: NCT02023060

Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation

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

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Key information

Conditions

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

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hadassah Medical Center, Jerusalem, Israel

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About this study

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

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Primary outcomes

  1. Clinical outcome of patients undergoing transcatheter valve replacement

    Time frame: 12 months

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

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Important dates

Study start
2013
Primary completion
2030
Study completion
2030
First posted
Dec 30, 2013
Registry last updated
Nov 29, 2023

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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