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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04585308




Registration number
NCT04585308
Ethics application status
Date submitted
5/10/2020
Date registered
14/10/2020

Titles & IDs
Public title
transShield Embolic Protection System Feasibility Study
Scientific title
Prospective, Multi-center, Single-Arm Feasibility Study of the transShield Embolic Protection System
Secondary ID [1] 0 0
CLP-05-001
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: Single arm - Patients with severe native aortic valve stenosis who meet the commercially approved indications for TAVR.


Treatment: Devices: transShield Embolic Protection System
Used for embolic protection during TAVR.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety - Incidence of 30-Day combined rate of the following events directly related to the transShield EPS as defined by VARC-2
Timepoint [1] 0 0
30 day combined rate post-procedure
Primary outcome [2] 0 0
Performance - Technical Success defined as the transShield EPS ability to perform all the following functions without adjudicated device malfunction
Timepoint [2] 0 0
During the procedure
Secondary outcome [1] 0 0
Safety - Incidence of minor vascular complications directly related to the transShield EPS as defined by VARC-2.
Timepoint [1] 0 0
30 days post-procedure

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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+)
* 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

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/03/2023
Sample size
Target
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Grafton
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton
Country [3] 0 0
Venezuela
State/province [3] 0 0
Caracas
Country [4] 0 0
Venezuela
State/province [4] 0 0
Sector La Feria

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
Mark Webster, MD
Address 0 0
Auckland City Hospital
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)?
No
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/NCT04585308