Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation

NCT ID: NCT02023060

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2030-11-30

Brief Summary

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

Detailed Description

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

Conditions

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Trans Catheter Aortic Valve Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Israel Barbash, MD

Role: STUDY_CHAIR

Sheba Medical Center, Tel Hashomer

Locations

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Hadassah Medical Center

Jerusalem, , Israel

Site Status RECRUITING

Shaarei Zedek amedical Center

Jerusalem, , Israel

Site Status RECRUITING

Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Israel Barbash, MD

Role: CONTACT

+97235305273

Facility Contacts

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Gideon Perlman

Role: primary

Elad Asher

Role: primary

Alon Barsheshet

Role: primary

Arik Steinvil

Role: primary

References

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Zusman O, Barbash MI, Guetta V, Finkelstein A, Assali A, Segev A, Orvin K, Barsheshet A, Younis A, Witberg G, Kornowski R, Danenberg H, Landes U. Predicting the risk of late futile outcome after transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2020 Dec;96(7):E695-E702. doi: 10.1002/ccd.28761. Epub 2020 Feb 5.

Reference Type DERIVED
PMID: 32022390 (View on PubMed)

Brodov Y, Konen E, Di Segni M, Samoocha D, Chernomordik F, Barbash I, Regev E, Raanani E, Guetta V, Segev A, Fefer P, Glikson M, Goitein O. Mitral Annulus Calcium Score. Circ Cardiovasc Imaging. 2019 Dec;12(1):e007508. doi: 10.1161/CIRCIMAGING.117.007508.

Reference Type DERIVED
PMID: 30636515 (View on PubMed)

Other Identifiers

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SHEBA-13-0685-IB-CTIL

Identifier Type: -

Identifier Source: org_study_id