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NCT02023060 Clinical Trial

Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation

Aortic Stenosis Clinical Trial

Official title:
Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02023060
Other study ID # SHEBA-13-0685-IB-CTIL
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2013
Est. completion date November 2030

Study information
Verified date June 2023
Source Sheba Medical Center
Contact Israel Barbash, MD
Phone +97235305273
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date November 2030
Est. primary completion date November 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years to 110 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Hadassah Medical Center Jerusalem
Israel Shaarei Zedek amedical Center Jerusalem
Israel Rabin Medical Center Petah tikva
Israel Sheba Medical Center Ramat Gan
Israel Tel Aviv Medical Center Tel Aviv

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical outcome of patients undergoing transcatheter valve replacement Mortality, change in New York Heart Association class, change in ejection fraction. 12 months
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