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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06652841




Registration number
NCT06652841
Ethics application status
Date submitted
30/09/2024
Date registered
22/10/2024
Date last updated
14/08/2025

Titles & IDs
Public title
Feasibility Study of the transShield Embolic Protection System
Scientific title
Prospective, Multi-center, Single Arm Feasibility Study of the transShield Embolic Protection System
Secondary ID [1] 0 0
CPL-06-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - transShield Embolic Protection System

Experimental: Patients with severe aortic valve stenosis scheduled for TAVR - transShield Embolic Protection System


Treatment: Devices: transShield Embolic Protection System
Patient undergoing TAVR procedure will receive the transShield EPS with the intent to capture and remove debris dislodged during the interventional procedure.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Performance Objective: Technical Success defined as tranShield EPS ability to perform all the following functions without adjudicated device malfunctions:
Timepoint [1] 0 0
During procedure
Primary outcome [2] 0 0
Safety Objective: MACCE at 30 Days
Timepoint [2] 0 0
30 day post procedure
Secondary outcome [1] 0 0
Embolic Debris Captured
Timepoint [1] 0 0
Procedure
Secondary outcome [2] 0 0
Incidence of Stroke
Timepoint [2] 0 0
Discharge and 30 Day Post-Procedure
Secondary outcome [3] 0 0
Adverse Events
Timepoint [3] 0 0
Up to 30 Days Post-procedure

Eligibility
Key inclusion criteria
1. Patient is =18 years old
2. Patient is scheduled for percutaneous TAVR using a commercial TAVR system
3. Patient meets indications for TAVR per the device IFU
4. The diameter of the artery at the site of the filter placement is = 42 mm
5. Size and condition of the femoral artery iliac arteries are appropriate for the 10F transShield Introducer
6. Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated procedures
7. Patient is willing and able to complete follow-up requirement
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient not undergoing TAVR via the trans-femoral route
2. Carotid artery stenosis > 70% in either carotid artery
3. Severe vascular tortuosity or anatomy that would preclude the safe introduction of the device
4. Aortic valve is a congenital unicuspid valve or is non-calcified
5. Predominant aortic regurgitation >3+
6. A known contraindication or hypersensitivity to all anticoagulation regimens or an inability to undergo anticoagulation for the study procedure
7. 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
8. Renal disease requiring chronic dialysis at time of treatment
9. History of stroke or transient ischemic attack (TIA) within prior 6 months
10. Evidence of an acute myocardial infarction (MI) within 30 days prior to study procedure
11. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within prior 30 days
12. Severe left ventricular (LV) dysfunction with LV ejection fraction (LVEF) <20%
13. Severe pulmonary hypertension and right ventricular (RV) dysfunction
14. Echocardiographic evidence of intracardiac mass, thrombus or vegetation
15. Life expectancy <12 months due to non-cardiac co-morbid conditions
16. Evidence of active systemic or local groin infection
17. 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
18. Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, ticlopidine, or clopidogrel, and/or contrast agents, that cannot be managed with premedication
19. 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
20. Known allergy to any device component
21. Known or suspected to be pregnant or lactating
22. Currently enrolled in an investigational drug or device clinical study in which the primary endpoint has not occurred
23. Patient has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/08/2025
Sample size
Target
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
TransAortic Medical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06652841