transShield Embolic Protection System Feasibility Study

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

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, (508) 254-1005, [email protected]

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