Feasibility Study of the transShield Embolic Protection System

August 11, 2025 updated by: TransAortic Medical, Inc.

Prospective, Multi-center, Single Arm Feasibility Study of the transShield Embolic Protection System

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients 18 years of age and older, with severe aortic valve stenosis scheduled for a Transcatheter Aortic Valve Replacement (TAVR) procedure will be screened to determine eligibility and interest in the study. Patients who pass pre-screen eligibility criteria and are willing to participate in the study will be asked to sign the study Informed Consent Form before any study-specific tests or procedures are performed or for any study specific evaluations not considered standard of care that need to be performed to assess eligibility. All subjects enrolled in the study will be followed from baseline through post procedure, prior to discharge and conclude with a 30-day followup visit. The investigator will perform the percutaneous TAVR using a commercial TAVR system according to their institution's standard practice. After completion of the procedure, the transShield EPS Filter will be collected and shipped to an independent Core Lab for histopathology assessment of the embolic debris captured in the filter. Post procedure treatment and safety monitoring shall be completed per the investigator's standard guidelines and patients discharged when clinically stable, at the investigator's discretion. Prior to discharge, functional status, physical exam/vital signs, medications, safety assessment and hospital stay information shall be collected. Patients will be asked to return to the investigational site 30 days post procedure for functional status, physical exam/vital signs, medications, and safety assessment. If the patient is not able to return to the investigational site, the visit may be completed via a tele-health visit with the investigator in combination with an in-office visit to the patient's local General Practitioner (GP) or Cardiologist. This visit will conclude the patient's participation in the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient is ≥18 years old
  2. Patient is scheduled for percutaneous TAVR using a commercial TAVR system
  3. Patient meets indications for TAVR per the device IFU
  4. The diameter of the artery at the site of the filter placement is ≤ 42 mm
  5. Size and condition of the femoral artery iliac arteries are appropriate for the 10F transShield Introducer
  6. Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated procedures
  7. Patient is willing and able to complete follow-up requirement

Exclusion Criteria:

  1. Patient not undergoing TAVR via the trans-femoral route
  2. Carotid artery stenosis > 70% in either carotid artery
  3. Severe vascular tortuosity or anatomy that would preclude the safe introduction of the device
  4. Aortic valve is a congenital unicuspid valve or is non-calcified
  5. Predominant aortic regurgitation >3+
  6. A known contraindication or hypersensitivity to all anticoagulation regimens or an inability to undergo anticoagulation for the study procedure
  7. 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
  8. Renal disease requiring chronic dialysis at time of treatment
  9. History of stroke or transient ischemic attack (TIA) within prior 6 months
  10. Evidence of an acute myocardial infarction (MI) within 30 days prior to study procedure
  11. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within prior 30 days
  12. Severe left ventricular (LV) dysfunction with LV ejection fraction (LVEF) <20%
  13. Severe pulmonary hypertension and right ventricular (RV) dysfunction
  14. Echocardiographic evidence of intracardiac mass, thrombus or vegetation
  15. Life expectancy <12 months due to non-cardiac co-morbid conditions
  16. Evidence of active systemic or local groin infection
  17. 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 severe atheroma (especially with calcification and surface irregularities) of the thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta
  18. Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, ticlopidine, or clopidogrel, and/or contrast agents, that cannot be managed with premedication

  19. 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

  20. Known allergy to any device component
  21. Known or suspected to be pregnant or lactating
  22. Currently enrolled in an investigational drug or device clinical study in which the primary endpoint has not occurred
  23. Patient has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients with severe aortic valve stenosis scheduled for TAVR
transShield Embolic Protection System
Device: transShield Embolic Protection System
Patient undergoing TAVR procedure will receive the transShield EPS with the intent to capture and remove debris dislodged during the interventional procedure.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Performance Objective: Technical Success defined as tranShield EPS ability to perform all the following functions without adjudicated device malfunctions:
Time Frame: During procedure
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
Time Frame: 30 day post procedure
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Embolic Debris Captured
Time Frame: Procedure
Volume of debris captured defined as the average number of captured particles great than or equal to 150 µm in diameter, as assessed by independent pathologist.
Procedure
Incidence of Stroke
Time Frame: Discharge and 30 Day Post-Procedure
Incidence of stroke according to VARC-3 definitions (subclassified ischemic, hemorrhagic, or undetermined, and as disabling or non-disabling) and TIA
Discharge and 30 Day Post-Procedure
Adverse Events
Time Frame: Up to 30 Days Post-procedure
Sunmary of all Adverse Events
Up to 30 Days Post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TransAortic Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 5, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CPL-06-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings