Aortic StenosisNCT04585308
transShield Embolic Protection System Feasibility Study
A study testing transShield Embolic Protection System in people with Aortic Stenosis, run by TransAortic Medical, Inc. at 4 sites in 2 countries.
Trial summary
The objective of this study is to evaluate the safety and performance of the transShield Embolic Protection System (EPS) used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR). 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?
- transShield Embolic Protection System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 15 Dec 2020to 13 Mar 2023
- 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
- Patients must meet all of the following criteria to be eligible for participation in the study:
- Patient is >18 years old
- Patient is scheduled for percutaneous TAVR with up to 20French compatible commercial TAVR system
- Patient meets indications for TAVR per the device Instructions For Use
- The diameter of the artery at the site of the filter placement is between 28 mm and 42 mm
- Size and condition of the femoral artery iliac arteries are appropriate for the 12French transShield Expandable Introducer and 20F Embolic Protection Device
- Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated procedures
- Patient is willing and able to complete follow-up requirements
Who cannot join
- Patients must be EXCLUDED from participation in this study if any of the following criteria are met:
- Patient not undergoing TAVR via the trans-femoral route
- Carotid artery stenosis >70% in either carotid artery
- Severe vascular tortuosity or anatomy that would preclude the safe introduction of the device
- Aortic valve is a congenital unicuspid or congenital bicuspid valve or is non-calcified
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+)
Show all 27Show fewer
- A known contraindication or hypersensitivity to all anticoagulation regimens or an inability to undergo anticoagulation for the study procedure
- History of bleeding diathesis or in whom anticoagulant and/or anti-platelet therapy is contraindicated, patients who will refuse transfusion, or havean active peptic ulcer or upper GI bleeding within the prior 3 months
- Renal insufficiency, defined as a creatinine level > 221μmol/L and/or end-stage renal disease requiring chronic dialysis at time of treatment
- History of stroke or transient ischemic attack (TIA) within prior 6 months
- Evidence of an acute myocardial infarction (MI) within prior 30 days
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within prior 30 days
- Hypertrophic cardiomyopathy with or without obstruction
- Need for emergency surgery for any reason
- Severe left ventricular (LV) dysfunction with LV ejection fraction (LVEF) <20%
- Severe pulmonary hypertension and right ventricular (RV) dysfunction
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Life expectancy < 12 months due to non-cardiac co-morbid conditions
- Evidence of active systemic or local groin infection
- Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta
- Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, or clopidogrel, or sensitivity to contrast media, that cannot be managed with premedication
- Planned other cardiac surgical procedure within 2 weeks prior to, or planned cardiac surgical or interventional procedure within 30 days after the TAVR procedure. Note: Diagnostic cardiac catheterization is permitted within 10 days prior to the TAVR procedure
- Neurodegenerative or other progressive neurological disease
- Known allergy to any device component
- Known or suspected to be pregnant or lactating
- Currently enrolled in an investigational drug or device clinical study in which the primary endpoint has not occurred
- Patient has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
New Zealand2 sites
Auckland City Hospital
Auckland, Grafton, 1142
Waikato Hospital
Hamilton, 3204
Venezuela2 sites
Ascardio Asociación Cardiovascular Centroccidental
La Lara, Sector La Feria, 3002
Policlinica Metropolitana, C.A
Miranda, Miranda, 1061
About this study
Official title: Prospective, Multi-center, Single-Arm Feasibility Study of the transShield Embolic Protection System
The objective of this study is to evaluate the safety and performance of the transShield Embolic Protection System (EPS) used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
Read the detailed description
This is a prospective, multi-center, single arm feasibility study to assess the safety and performance of the transShield EPS. Patients with severe native aortic valve stenosis scheduled for TAVR will be screened for study eligibility. Subjects who meet the commercially approved indications for TAVR and comply with the study inclusion/exclusion criteria are eligible for enrollment. Patients will be followed for 30 days post procedure.
- Conditions
- Aortic Stenosis
- Being tested
- transShield Embolic Protection System
- 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.
transShield Embolic Protection SystemDevice
Used for embolic protection during TAVR.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Patients with severe native aortic valve stenosis who meet the commercially approved indications for TAVR. Receives: Device: transShield Embolic Protection System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Incidence of 30-Day combined rate of the following events directly related to the transShield EPS as defined by VARC-2
- Major Adverse Cardiac and Cerebrovascular Events (MACCE)
- All cause mortality
- All cause stroke (disabling and non-disabling)
- Acute kidney injury (Stage 2 or 3)
- Major vascular complications
Measured: 30 day combined rate post-procedure
Performance - Technical Success defined as the transShield EPS ability to perform all the following functions without adjudicated device malfunction
- Ability to successfully deploy the device in the correct anatomical position, in the ascending aorta without interference with TAVR procedure/devices
- Ability to retrieve and remove the device intact, including no visual evidence of any filter damage
Measured: During the procedure
Secondary outcomes (1)
Safety - Incidence of minor vascular complications directly related to the transShield EPS as defined by VARC-2.
- As defined by VARC-2.
- Incidence of peri-procedural disabling stroke as defined by a modified Rankin Scale (mRS) score of 2 or more at 30 days and an increase in at least one mRS category from an individual's pre-stroke baseline.
Measured: 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start15 Dec 2020
- Primary completion13 Mar 2023
- Study completion13 Mar 2023
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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- TransAortic Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Webster, MD, Principal investigator, Auckland City HospitalCarlos Calderas, MD, Principal investigator, Policlinica Metropolitana - Venezuela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585308
- Sponsor's protocol ID
- CLP-05-001
- Status last verified
- Nov 2023
- First submitted
- 5 Oct 2020
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Single-Arm Feasibility Study of the transShield Embolic Protection System
- ClinicalTrials.gov ID
- NCT04585308
- Acronym / sponsor ID
- CLP-05-001
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- TransAortic Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 13 Mar 2023 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 14 Oct 2020 (actual)
- 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 of this study is to evaluate the safety and performance of the transShield Embolic Protection System (EPS) used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
Detailed description
This is a prospective, multi-center, single arm feasibility study to assess the safety and performance of the transShield EPS. Patients with severe native aortic valve stenosis scheduled for TAVR will be screened for study eligibility. Subjects who meet the commercially approved indications for TAVR and comply with the study inclusion/exclusion criteria are eligible for enrollment. Patients will be followed for 30 days post procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: transShield Embolic Protection SystemPatients with severe native aortic valve stenosis who meet the commercially approved indications for TAVR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must meet all of the following criteria to be eligible for participation in the study:
Key exclusion criteria (27 listed)
- Patients must be EXCLUDED from participation in this study if any of the following criteria are met:
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 |
|---|---|---|
| transShield Embolic Protection SystemUsed for embolic protection during TAVR. | Device | Single arm |
Primary outcome
Safety - Incidence of 30-Day combined rate of the following events directly related to the transShield EPS as defined by VARC-2
Time frame: 30 day combined rate post-procedure
* Major Adverse Cardiac and Cerebrovascular Events (MACCE) * All cause mortality * All cause stroke (disabling and non-disabling) * Acute kidney injury (Stage 2 or 3) * Major vascular complications
Performance - Technical Success defined as the transShield EPS ability to perform all the following functions without adjudicated device malfunction
Time frame: During the procedure
* Ability to successfully deploy the device in the correct anatomical position, in the ascending aorta without interference with TAVR procedure/devices * Ability to retrieve and remove the device intact, including no visual evidence of any filter damage
1 secondary outcome
Safety - Incidence of minor vascular complications directly related to the transShield EPS as defined by VARC-2.
Time frame: 30 days post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Mark Webster, MD principal investigator
Auckland City Hospital
Carlos Calderas, MD principal investigator
Policlinica Metropolitana - Venezuela
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transShield Embolic Protection System in people with Aortic Stenosis, run by TransAortic Medical, Inc. at 4 sites in 2 countries.
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 8 inclusion and 27 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: finished, as of the sponsor's last update on 22 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 4 sites in New Zealand, Venezuela. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Incidence of 30-Day combined rate of the following events directly related to the transShield EPS as defined by VARC-2 (time frame: 30 day combined rate 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 22 Nov 2023; AzTrials last refreshed its copy on 28 Oct 2026.