Severe Symptomatic Aortic StenosisNCT02210351
Evaluation of Association Between Apical Dysfunction and Trans Apical Access for TAVR, in Patients With Severe Aortic Stenosis, Undergoing Trans Apical Trans Catheter Aortic Valve Replacement (TAP-TAVR).
A study testing MRI test in people with Severe Symptomatic Aortic Stenosis, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The asses and evaluate whether trans apical access for TAVR is associated with apical dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Symptomatic Aortic Stenosis
- What is being tested?
- MRI test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography.
- Symptomatic patients with aortic stenosis referred for medically indicated AVR
- Signed informed consent to participate in the study.
Who cannot join
- Inability to sign written informed consent.
- Abnormal Apical dysfunction at baseline
- LVEF < 20%
- Pregnancy or breast feeding.
- Need for emergency surgery for any reason.
- Any case in which the practicing physician asserts that enrollment in the protocol will
Trial locations and contacts
1 site in 1 country.
Israel1 site
Leviev Heart Center, Sheba Medical Center
Ramat Gan, 5265601
Danny Spiegelstein, Dr, 972-35307339, Danny.Spiegelstein@sheba.health.gov.il
About this study
The asses and evaluate whether trans apical access for TAVR is associated with apical dysfunction.
- Conditions
- Severe Symptomatic Aortic Stenosis
- Being tested
- MRI test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI testDevice
| Study group | Role | What they receive |
|---|---|---|
| MRI test | Experimental | Not described Receives: Device: MRI test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricle ejection fraction
Measured: two months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Symptomatic Aortic StenosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Danny Spiegelstein, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210351
- Sponsor's protocol ID
- SHEBA-13-0829-DS-CTIL
- Status last verified
- Aug 2014
- First submitted
- 5 Aug 2014
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Association Between Apical Dysfunction and Trans Apical Access for TAVR, in Patients With Severe Aortic Stenosis, Undergoing Trans Apical Trans Catheter Aortic Valve Replacement (TAP-TAVR).
- ClinicalTrials.gov ID
- NCT02210351
- Acronym / sponsor ID
- SHEBA-13-0829-DS-CTIL
- Conditions
- Severe Symptomatic Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2014
- Primary completion
- Jan 2017 (estimated)
- First posted
- 6 Aug 2014 (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 asses and evaluate whether trans apical access for TAVR is associated with apical dysfunction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI test | Experimental | Device: MRI test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography.
- Symptomatic patients with aortic stenosis referred for medically indicated AVR
- Signed informed consent to participate in the study.
Key exclusion criteria (6 listed)
- Inability to sign written informed consent.
- Abnormal Apical dysfunction at baseline
- LVEF < 20%
- Pregnancy or breast feeding.
- Need for emergency surgery for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI test | Device | MRI test |
Primary outcome
Change in left ventricle ejection fraction
Time frame: two months after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI test in people with Severe Symptomatic Aortic Stenosis, run by Sheba Medical Center at 1 site 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danny Spiegelstein, Dr (972-35307339, Danny.Spiegelstein@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricle ejection fraction (time frame: two months after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2014.