Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04585308
Registration number
NCT04585308
Ethics application status
Date submitted
5/10/2020
Date registered
14/10/2020
Date last updated
22/11/2023
Titles & IDs
Public title
transShield Embolic Protection System Feasibility Study
Query!
Scientific title
Prospective, Multi-center, Single-Arm Feasibility Study of the transShield Embolic Protection System
Query!
Secondary ID [1]
0
0
CLP-05-001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Aortic Stenosis
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
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
Query!
Assessment method [1]
0
0
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
Query!
Timepoint [1]
0
0
30 day combined rate post-procedure
Query!
Primary outcome [2]
0
0
Performance - Technical Success defined as the transShield EPS ability to perform all the following functions without adjudicated device malfunction
Query!
Assessment method [2]
0
0
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
Query!
Timepoint [2]
0
0
During the procedure
Query!
Secondary outcome [1]
0
0
Safety - Incidence of minor vascular complications directly related to the transShield EPS as defined by VARC-2.
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
30 days post-procedure
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
15/12/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
13/03/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
28
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
New Zealand
Query!
State/province [1]
0
0
Grafton
Query!
Country [2]
0
0
New Zealand
Query!
State/province [2]
0
0
Hamilton
Query!
Country [3]
0
0
Venezuela
Query!
State/province [3]
0
0
Caracas
Query!
Country [4]
0
0
Venezuela
Query!
State/province [4]
0
0
Sector La Feria
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
TransAortic Medical, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04585308
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Mark Webster, MD
Query!
Address
0
0
Auckland City Hospital
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04585308
Download to PDF