Aortic StenosisNCT06652841
Feasibility Study of the transShield Embolic Protection System
A study testing transShield Embolic Protection System in people with Aortic Stenosis, run by TransAortic Medical, Inc. at 1 site in New Zealand.
Trial summary
The objective of this study is to evaluate the initial safety and performance of the transShield 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
- 2 participants
- Where
- 1 siteNew Zealand
- Study dates
- 26 Mar 2025to 5 Aug 2025
- 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
- Patient is ≥18 years old
- Patient is scheduled for percutaneous TAVR using a commercial TAVR system
- Patient meets indications for TAVR per the device IFU
- The diameter of the artery at the site of the filter placement is ≤ 42 mm
- Size and condition of the femoral artery iliac arteries are appropriate for the 10F transShield Introducer
- 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 requirement
Who cannot join
- 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 valve or is non-calcified
- Predominant aortic regurgitation >3+
- A known contraindication or hypersensitivity to all anticoagulation regimens or an inability to undergo anticoagulation for the study procedure
Show all 24Show fewer
- History of bleeding diathesis or in whom anticoagulant and/or anti- platelet therapy is contraindicated, patients who will refuse transfusion, or have an active peptic ulcer or upper GI bleeding within the prior 3 months
- 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 30 days prior to study procedure
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within prior 30 days
- 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 severe atheroma (especially with calcification and surface irregularities) of the thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta
- Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, ticlopidine, or clopidogrel, and/or contrast agents, 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
- 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
1 site in 1 country.
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 initial safety and performance of the transShield EPS used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
Read the detailed description
Patients 18 years of age and older, with severe aortic valve stenosis scheduled for a Transcatheter Aortic Valve Replacement (TAVR) procedure will be screened to determine eligibility and interest in the study. Patients who pass pre-screen eligibility criteria and are willing to participate in the study will be asked to sign the study Informed Consent Form before any study-specific tests or procedures are performed or for any study specific evaluations not considered standard of care that need to be performed to assess eligibility. All subjects enrolled in the study will be followed from baseline through post procedure, prior to discharge and conclude with a 30-day followup visit. The investigator will perform the percutaneous TAVR using a commercial TAVR system according to their institution's standard practice. After completion of the procedure, the transShield EPS Filter will be collected and shipped to an independent Core Lab for histopathology assessment of the embolic debris captured in the filter. Post procedure treatment and safety monitoring shall be completed per the investigator's standard guidelines and patients discharged when clinically stable, at the investigator's discretion. Prior to discharge, functional status, physical exam/vital signs, medications, safety assessment and hospital stay information shall be collected. Patients will be asked to return to the investigational site 30 days post procedure for functional status, physical exam/vital signs, medications, and safety assessment. If the patient is not able to return to the investigational site, the visit may be completed via a tele-health visit with the investigator in combination with an in-office visit to the patient's local General Practitioner (GP) or Cardiologist. This visit will conclude the patient's participation in the study.
- Conditions
- Aortic Stenosis
- Being tested
- transShield Embolic Protection System
- Keywords
- Aortic Stenosis
- 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
Patient undergoing TAVR procedure will receive the transShield EPS with the intent to capture and remove debris dislodged during the interventional procedure.
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe aortic valve stenosis scheduled for TAVR | Experimental | transShield Embolic Protection System Receives: Device: transShield Embolic Protection System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Objective: Technical Success defined as tranShield EPS ability to perform all the following functions without adjudicated device malfunctions:
Ability to successfully deploy the device in the correct anatomical position, in the ascending aorta without interference with TAVR procedure/devices, and ability to retrieve and remove the device intact, including no visual evidence of any filter damage.
Measured: During procedure
Safety Objective: MACCE at 30 Days
Defined as incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 days according to VARC-3 including: All cause mortality, All stroke (disabling and non-disabling) and TIA, Acute kidney injury (stage 2 or 3), Major vascular and access-related complications, and Life-threatening or disabling bleeding (type 2-4).
Measured: 30 day post procedure
Secondary outcomes (3)
Embolic Debris Captured
Volume of debris captured defined as the average number of captured particles great than or equal to 150 µm in diameter, as assessed by independent pathologist.
Measured: Procedure
Incidence of Stroke
Incidence of stroke according to VARC-3 definitions (subclassified ischemic, hemorrhagic, or undetermined, and as disabling or non-disabling) and TIA
Measured: Discharge and 30 Day Post-Procedure
Adverse Events
Sunmary of all Adverse Events
Measured: Up to 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 posted22 Oct 2024
- Study start26 Mar 2025
- Primary completion5 Aug 2025
- Study completion5 Aug 2025
Why it stopped: Study Sponsor closing study due to financial circumstances.
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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- TransAortic Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652841
- Sponsor's protocol ID
- CPL-06-001
- Status last verified
- Aug 2025
- First submitted
- 30 Sep 2024
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. 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
- NCT06652841
- Acronym / sponsor ID
- CPL-06-001
- Conditions
- Aortic Stenosis
- Keywords
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study Sponsor closing study due to financial circumstances.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- TransAortic Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 5 Aug 2025 (actual)
- First posted
- 22 Oct 2024 (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 initial safety and performance of the transShield EPS used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
Detailed description
Patients 18 years of age and older, with severe aortic valve stenosis scheduled for a Transcatheter Aortic Valve Replacement (TAVR) procedure will be screened to determine eligibility and interest in the study. Patients who pass pre-screen eligibility criteria and are willing to participate in the study will be asked to sign the study Informed Consent Form before any study-specific tests or procedures are performed or for any study specific evaluations not considered standard of care that need to be performed to assess eligibility. All subjects enrolled in the study will be followed from baseline through post procedure, prior to discharge and conclude with a 30-day followup visit. The investigator will perform the percutaneous TAVR using a commercial TAVR system according to their institution's standard practice. After completion of the procedure, the transShield EPS Filter will be collected and shipped to an independent Core Lab for histopathology assessment of the embolic debris captured in the filter. Post procedure treatment and safety monitoring shall be completed per the investigator's standard guidelines and patients discharged when clinically stable, at the investigator's discretion. Prior to discharge, functional status, physical exam/vital signs, medications, safety assessment and hospital stay information shall be collected. Patients will be asked to return to the investigational site 30 days post procedure for functional status, physical exam/vital signs, medications, and safety assessment. If the patient is not able to return to the investigational site, the visit may be completed via a tele-health visit with the investigator in combination with an in-office visit to the patient's local General Practitioner (GP) or Cardiologist. This visit will conclude the patient's participation in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe aortic valve stenosis scheduled for TAVR | Experimental | Device: transShield Embolic Protection SystemtransShield Embolic Protection System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is ≥18 years old
- Patient is scheduled for percutaneous TAVR using a commercial TAVR system
- Patient meets indications for TAVR per the device IFU
- The diameter of the artery at the site of the filter placement is ≤ 42 mm
- Size and condition of the femoral artery iliac arteries are appropriate for the 10F transShield Introducer
Key exclusion criteria (24 listed)
- 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 valve or is non-calcified
- Predominant aortic regurgitation >3+
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 SystemPatient undergoing TAVR procedure will receive the transShield EPS with the intent to capture and remove debris dislodged during the interventional procedure. | Device | Patients with severe aortic valve stenosis scheduled for TAVR |
Primary outcome
Performance Objective: Technical Success defined as tranShield EPS ability to perform all the following functions without adjudicated device malfunctions:
Time frame: During procedure
Ability to successfully deploy the device in the correct anatomical position, in the ascending aorta without interference with TAVR procedure/devices, and ability to retrieve and remove the device intact, including no visual evidence of any filter damage.
Safety Objective: MACCE at 30 Days
Time frame: 30 day post procedure
Defined as incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 days according to VARC-3 including: All cause mortality, All stroke (disabling and non-disabling) and TIA, Acute kidney injury (stage 2 or 3), Major vascular and access-related complications, and Life-threatening or disabling bleeding (type 2-4).
3 secondary outcomes
Embolic Debris Captured
Time frame: Procedure
Incidence of Stroke
Time frame: Discharge and 30 Day Post-Procedure
Adverse Events
Time frame: Up to 30 Days Post-procedure
Results and safety
The study was stopped early (reason given: Study Sponsor closing study due to financial circumstances.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: 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 1 site in New Zealand.
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 7 inclusion and 24 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: stopped early, as of the sponsor's last update on 14 Aug 2025. 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 New Zealand. 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 was stopped early (reason given: Study Sponsor closing study due to financial circumstances.). Results are not available in the source record.
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?
Performance Objective: Technical Success defined as tranShield EPS ability to perform all the following functions without adjudicated device malfunctions: (time frame: During 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 14 Aug 2025.