transShield Embolic Protection System Feasibility Study

NCT04585308 | Completed

• 1 other identifier: CLP-05-001
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 4

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).

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (2)

• Safety - Incidence of 30-Day combined rate of the following events directly related to the transShield EPS as defined by VARC-2

  * 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

  30 day combined rate post-procedure

• Performance - Technical Success defined as the transShield EPS ability to perform all the following functions without adjudicated device malfunction

  * 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

  During the procedure

Secondary Outcomes (1)

• Safety - Incidence of minor vascular complications directly related to the transShield EPS as defined by VARC-2.

  30 days post-procedure

Study Arms (1)

Single arm

EXPERIMENTAL

Patients with severe native aortic valve stenosis who meet the commercially approved indications for TAVR.

Device: transShield Embolic Protection System

Interventions

transShield Embolic Protection System DEVICE

Used for embolic protection during TAVR.

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• TransAortic Medical, Inc.: lead

Study Sites (4)

Auckland City Hospital

Auckland, Grafton, 1142, New Zealand

Location

Waikato Hospital

Hamilton, 3204, New Zealand

Location

Policlinica Metropolitana, C.A

Miranda, Miranda, 1061, Venezuela

Location

Ascardio Asociación Cardiovascular Centroccidental

La Lara, Sector La Feria, 3002, Venezuela

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Mark Webster, MD

  Auckland City Hospital

  PRINCIPAL INVESTIGATOR

• Carlos Calderas, MD

  Policlinica Metropolitana - Venezuela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 14, 2020
• Study Start: December 15, 2020
• Primary Completion: March 13, 2023
• Study Completion: March 13, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2); VE (2)