Aortic StenosisBAVNCT02617524
Dedicated Sheath Feasibility Study
A study testing Valve Medical Dedicated Sheath version 00 in people with Aortic Stenosis, run by Valve Medical at 1 site in Israel.
Trial summary
Dedicated Sheath feasibility study: A prospective, open-label study to evaluate the feasibility and safety of the Valve Medical Dedicated Sheath during Balloon Aortic Valvuloplasty (BAV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Valve Medical Dedicated Sheath version 00
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2016to Aug 2016
- 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
- Age ≥ 18 years.
- Patient understands the implications of participating in the study and provides written informed consent.
- The patient has an indication for balloon aortic valvuloplasty (BAV).
Who cannot join
- Peripheral vessel anatomy or peripheral vascular disease that would preclude the insertion of the 12 Fr. sheath.
- Any illness or condition which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Center
Jerusalem
Galina Levin, 972 2 6778914, lenving@hadassah.org.il
Haim Danenberg, M.D., PhD
About this study
Official title: A Prospective, Open-label Study to Evaluate the Feasibility and Safety of the Valve Medical Dedicated Sheath During Balloon Aortic Valvuloplasty
Dedicated Sheath feasibility study: A prospective, open-label study to evaluate the feasibility and safety of the Valve Medical Dedicated Sheath during Balloon Aortic Valvuloplasty (BAV).
Read the detailed description
This is an open-label, prospective, single arm clinical study. Up to 15 patients undergoing valvular intervention will be enrolled. Follow up will take place at 1, 6 and 24 hours post procedure. No follow up visits are required.
During the study, the patient will undergo the following tests:
- Physical examination (includes blood pressure, age, height, weight).
- Echo assessments prior to procedure.
- Hemodynamic study prior and post BAV.
- Full blood count
- Angiography
- Conditions
- Aortic Stenosis
- Being tested
- Valve Medical Dedicated Sheath version 00
- Keywords
- dedicated sheath
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valve Medical Dedicated Sheath version 00Device
The Valve Medical Dedicated Sheath is intended to be used as an introducer sheath during BAV procedures
| Study group | Role | What they receive |
|---|---|---|
| Valve Medical Dedicated Sheath | Experimental | Valve Medical Dedicated Sheath version 00 Receives: Device: Valve Medical Dedicated Sheath version 00 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device success
Measured: Outcome measures will be assessed at 1, 6 and 24 hours post procedure.
Procedure Safety: Adverse Event Assessment for device related and unrelated events
Measured: Outcome measures will be assessed at enrollment, throughout the procedure and 1, 6 and 24 hours post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJul 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valve Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medinol Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617524
- Sponsor's protocol ID
- CLICL 01446
- Acronym
- BAV
- Status last verified
- Jan 2016
- First submitted
- 24 Nov 2015
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label Study to Evaluate the Feasibility and Safety of the Valve Medical Dedicated Sheath During Balloon Aortic Valvuloplasty
- ClinicalTrials.gov ID
- NCT02617524
- Acronym / sponsor ID
- BAV / CLICL 01446
- Conditions
- Aortic Stenosis
- Keywords
- dedicated sheath
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Valve MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Medinol Ltd.
- Study start
- Jan 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 1 Dec 2015 (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.
Dedicated Sheath feasibility study: A prospective, open-label study to evaluate the feasibility and safety of the Valve Medical Dedicated Sheath during Balloon Aortic Valvuloplasty (BAV).
Detailed description
This is an open-label, prospective, single arm clinical study. Up to 15 patients undergoing valvular intervention will be enrolled. Follow up will take place at 1, 6 and 24 hours post procedure. No follow up visits are required.
During the study, the patient will undergo the following tests:
- Physical examination (includes blood pressure, age, height, weight).
- Echo assessments prior to procedure.
- Hemodynamic study prior and post BAV.
- Full blood count
- Angiography
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valve Medical Dedicated Sheath | Experimental | Device: Valve Medical Dedicated Sheath version 00Valve Medical Dedicated Sheath version 00 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Patient understands the implications of participating in the study and provides written informed consent.
- The patient has an indication for balloon aortic valvuloplasty (BAV).
Key exclusion criteria (2 listed)
- Peripheral vessel anatomy or peripheral vascular disease that would preclude the insertion of the 12 Fr. sheath.
- Any illness or condition which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.
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 |
|---|---|---|
| Valve Medical Dedicated Sheath version 00The Valve Medical Dedicated Sheath is intended to be used as an introducer sheath during BAV procedures | Device | Valve Medical Dedicated Sheath |
Primary outcome
Device success
Time frame: Outcome measures will be assessed at 1, 6 and 24 hours post procedure.
Procedure Safety: Adverse Event Assessment for device related and unrelated events
Time frame: Outcome measures will be assessed at enrollment, throughout the procedure and 1, 6 and 24 hours post procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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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 Valve Medical Dedicated Sheath version 00 in people with Aortic Stenosis, run by Valve Medical 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 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: status not confirmed, as of the sponsor's last update on 20 Jan 2016. 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 Mor Buchshtav, M.Sc. (972 3 7679000 ext. 3514, morb@medinol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device success (time frame: Outcome measures will be assessed at 1, 6 and 24 hours post procedure.). The study lists 2 primary outcomes in all. 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 20 Jan 2016.