Recruiting NCT02023060
Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Trans Catheter Aortic Valve, Aortic Stenosis. Basic parameters: 18 years — 110 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Clinical outcome of patients undergoing transcatheter valve replacement [Time frame: 12 months]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Israel · 5 centers
- Hadassah Medical Center — Jerusalem
- Shaarei Zedek amedical Center — Jerusalem
- Rabin Medical Center — Petah Tikva
- Sheba Medical Center — Ramat Gan
- Tel Aviv Medical Center — Tel Aviv
Publications
- 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. PMID 32022390
- 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. PMID 30636515
Identifiers
NCT: NCT02023060 · SHEBA-13-0685-IB-CTIL