Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation

November 26, 2023 updated by: Sheba Medical Center
The objective is to observe trends in patient characteristics and outcomes after aortic or mitral transcatheter heart valve replacement over time.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Israel Barbash, MD
  • Phone Number: +97235305273

Study Locations

  • Israel
      • Jerusalem, Israel
        • Recruiting
        • Hadassah Medical Center
        • Contact:
          • Gideon Perlman
      • Jerusalem, Israel
        • Recruiting
        • Shaarei Zedek amedical Center
        • Contact:
          • Elad Asher
      • Petah tikva, Israel
        • Recruiting
        • Rabin Medical Center
        • Contact:
          • Alon Barsheshet
      • Ramat Gan, Israel
        • Recruiting
        • Sheba Medical Center
      • Tel Aviv, Israel
        • Recruiting
        • Tel Aviv Medical Center
        • Contact:
          • Arik Steinvil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Subjects with severe aortic or mitral valve dysfunction (stenosis or regurgitation) selected for transcatheter aortic or mitral valve replacement

Description

Inclusion Criteria:

  1. Subject selected for transcatheter heart valve replacement
  2. Signed informed consent to participate in the study

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome of patients undergoing transcatheter valve replacement
Time Frame: 12 months
Mortality, change in New York Heart Association class, change in ejection fraction.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Study Chair: Israel Barbash, MD, Sheba Medical Center, Tel Hashomer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 1, 2030

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

December 22, 2013

First Posted (Estimated)

December 30, 2013

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-13-0685-IB-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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