Brief Title
transShield Embolic Protection System Feasibility Study
Official Title
Prospective, Multi-center, Single-Arm Feasibility Study of the transShield Embolic Protection System
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).
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 Type
Interventional
Primary Outcome
Safety - Incidence of 30-Day combined rate of the following events directly related to the transShield EPS as defined by VARC-2
Secondary Outcome
Safety - Incidence of minor vascular complications directly related to the transShield EPS as defined by VARC-2.
Condition
Aortic Stenosis
Intervention
transShield Embolic Protection System
Study Arms / Comparison Groups
Single arm
Description: Patients with severe native aortic valve stenosis who meet the commercially approved indications for TAVR.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
50
Start Date
December 15, 2020
Completion Date
September 2021
Primary Completion Date
August 2021
Eligibility Criteria
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
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Mark Webster, MD, ,
Location Countries
New Zealand
Location Countries
New Zealand
Administrative Informations
NCT ID
NCT04585308
Organization ID
CLP-05-001
Responsible Party
Sponsor
Study Sponsor
TransAortic Medical, Inc.
Study Sponsor
Mark Webster, MD, Principal Investigator, Auckland City Hospital
Verification Date
January 2021