Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation

Recruiting

• Conditions: Trans Catheter Aortic Valve; Aortic Stenosis

• Registration Number: NCT02023060
• Lead Sponsor: Sheba Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-22
• Study First Posted: 2013-12-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-11-26
• Last Update Posted: 2023-11-29
• Primary Completion: 2030-11
• Study Completion: 2030-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical outcome of patients undergoing transcatheter valve replacement	12 months	Mortality, change in New York Heart Association class, change in ejection fraction.

Trial Locations

Locations (5)

Rabin Medical Center; 🇮🇱 Petah tikva, Israel

Shaarei Zedek amedical Center; 🇮🇱 Jerusalem, Israel

Tel Aviv Medical Center; 🇮🇱 Tel Aviv, Israel

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel