Feasibility Study of the transShield Embolic Protection System

NCT06652841 | Terminated FDA Device

• 1 other identifier: CPL-06-001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the initial safety and performance of the transShield EPS used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).

Conditions

Aortic Stenosis

Keywords

Aortic Stenosis

Outcome Measures

Primary Outcomes (2)

• Performance Objective: Technical Success defined as tranShield EPS ability to perform all the following functions without adjudicated device malfunctions:

  Ability to successfully deploy the device in the correct anatomical position, in the ascending aorta without interference with TAVR procedure/devices, and ability to retrieve and remove the device intact, including no visual evidence of any filter damage.

  During procedure

• Safety Objective: MACCE at 30 Days

  Defined as incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 days according to VARC-3 including: All cause mortality, All stroke (disabling and non-disabling) and TIA, Acute kidney injury (stage 2 or 3), Major vascular and access-related complications, and Life-threatening or disabling bleeding (type 2-4).

  30 day post procedure

Secondary Outcomes (3)

• Embolic Debris Captured

  Procedure

• Incidence of Stroke

  Discharge and 30 Day Post-Procedure

• Adverse Events

  Up to 30 Days Post-procedure

Study Arms (1)

Patients with severe aortic valve stenosis scheduled for TAVR

EXPERIMENTAL

transShield Embolic Protection System

Device: transShield Embolic Protection System

Interventions

transShield Embolic Protection System DEVICE

Patient undergoing TAVR procedure will receive the transShield EPS with the intent to capture and remove debris dislodged during the interventional procedure.

Patients with severe aortic valve stenosis scheduled for TAVR

Eligibility Criteria

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

You may qualify if:

• Patient is ≥18 years old
• Patient is scheduled for percutaneous TAVR using a commercial TAVR system
• Patient meets indications for TAVR per the device IFU
• The diameter of the artery at the site of the filter placement is ≤ 42 mm
• Size and condition of the femoral artery iliac arteries are appropriate for the 10F transShield Introducer
• 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 requirement

You may not qualify if:

• 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 valve or is non-calcified
• 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 have an active peptic ulcer or upper GI bleeding within the prior 3 months
• 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 30 days prior to study procedure
• Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within prior 30 days
• 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

Sponsors & Collaborators

• TransAortic Medical, Inc.: lead

Study Sites (1)

Waikato Hospital

Hamilton, New Zealand

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

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: September 30, 2024
• First Posted: October 22, 2024
• Study Start: March 26, 2025
• Primary Completion: August 5, 2025
• Study Completion: August 5, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

NZ (1)