Trans Catheter Aortic ValveNCT02023060
Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation
An observational study of Trans Catheter Aortic Valve and Aortic Stenosis, run by Sheba Medical Center at 5 sites in Israel.
Trial summary
The objective is to observe trends in patient characteristics and outcomes after aortic or mitral transcatheter heart valve replacement over time. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Trans Catheter Aortic Valve, Aortic Stenosis
- How many people
- 100 participants
- Where
- 5 sitesIsrael
- Study dates
- Nov 2013to Nov 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with severe aortic or mitral valve dysfunction (stenosis or regurgitation) selected for transcatheter aortic or mitral valve replacement
Who may be able to join
- Subject selected for transcatheter heart valve replacement
- Signed informed consent to participate in the study
Who cannot join
- Inability to sign written informed consent.
- Pregnancy or breast feeding (women of childbearing potential will have a serum or urine pregnancy test).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel Barbash, MD contact
5 sites in 1 country
Israel5 sites, 5 recruiting
- Recruiting
Hadassah Medical Center
Jerusalem
Gideon Perlman
- Recruiting
Shaarei Zedek amedical Center
Jerusalem
Elad Asher
- Recruiting
Rabin Medical Center
Petah Tikva
Alon Barsheshet
- Recruiting
Sheba Medical Center
Ramat Gan
- Recruiting
Tel Aviv Medical Center
Tel Aviv
Arik Steinvil
About this study
The objective is to observe trends in patient characteristics and outcomes after aortic or mitral transcatheter heart valve replacement over time.
Read the detailed description
To observe trends in patient characteristics and outcomes after aortic or mitral transcatheter heart valve replacement over time.
- Conditions
- Trans Catheter Aortic Valve, Aortic Stenosis
- Medical subject headings
- Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome of patients undergoing transcatheter valve replacement
Mortality, change in New York Heart Association class, change in ejection fraction.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Trans Catheter Aortic ValveStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Israel Barbash, MD, Study chair, Sheba Medical Center, Tel Hashomer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023060
- Sponsor's protocol ID
- SHEBA-13-0685-IB-CTIL
- Status last verified
- Jun 2023
- First submitted
- 9 Dec 2013
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 32022390Brodov 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.
PubMed 30636515
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation
- ClinicalTrials.gov ID
- NCT02023060
- Acronym / sponsor ID
- SHEBA-13-0685-IB-CTIL
- Conditions
- Trans Catheter Aortic Valve, Aortic Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Nov 2013
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with severe aortic or mitral valve dysfunction (stenosis or regurgitation) selected for transcatheter aortic or mitral valve replacement
Key inclusion criteria (2 listed)
- Subject selected for transcatheter heart valve replacement
- Signed informed consent to participate in the study
Key exclusion criteria (2 listed)
- Inability to sign written informed consent.
- Pregnancy or breast feeding (women of childbearing potential will have a serum or urine pregnancy test).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical outcome of patients undergoing transcatheter valve replacement
Time frame: 12 months
Mortality, change in New York Heart Association class, change in ejection fraction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 32022390Zusman 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.
- Derived from this study: PubMed 30636515Brodov 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Israel Barbash, MD contact
Israel Barbash, MD study chair
Sheba Medical Center, Tel Hashomer
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trans Catheter Aortic Valve and Aortic Stenosis, run by Sheba Medical Center at 5 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Israel Barbash, MD (+97235305273), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome of patients undergoing transcatheter valve replacement (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02023060, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.