transShield Embolic Protection System Feasibility Study

November 20, 2023 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 safety and performance of the transShield Embolic Protection System (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.
Completed

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

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

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.
28

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 Contact Backup

Study Locations

  • New Zealand
      • Hamilton, New Zealand, 3204
        • Waikato Hospital
    • Grafton
      • Auckland, Grafton, New Zealand, 1142
        • Auckland City Hospital
  • Venezuela
    • Caracas
      • Miranda, Caracas, Venezuela, 1061
        • Policlinica Metropolitana, C.A
    • Sector La Feria
      • La Lara, Sector La Feria, Venezuela, 3002
        • Ascardio Asociación Cardiovascular Centroccidental

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
    • Evidence of active systemic or local groin infection
    • 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 narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta
    • Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, or clopidogrel, or sensitivity to contrast media, that cannot be managed with premedication
    • 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
    • Neurodegenerative or other progressive neurological disease
    • Known allergy to any device component
    • Known or suspected to be pregnant or lactating
    • Currently enrolled in an investigational drug or device clinical study in which the primary endpoint has not occurred
    • 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: Single arm
Patients with severe native aortic valve stenosis who meet the commercially approved indications for TAVR.
Device: transShield Embolic Protection System
Used for embolic protection during TAVR.

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
Safety - Incidence of 30-Day combined rate of the following events directly related to the transShield EPS as defined by VARC-2
Time Frame: 30 day combined rate post-procedure

  • 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
Time Frame: During the procedure
  • 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 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
Safety - Incidence of minor vascular complications directly related to the transShield EPS as defined by VARC-2.
Time Frame: 30 days post-procedure
  • As defined by VARC-2.
  • Incidence of peri-procedural disabling stroke as defined by a modified Rankin Scale (mRS) score of 2 or more at 30 days and an increase in at least one mRS category from an individual's pre-stroke baseline.
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.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark Webster, MD, Auckland City Hospital
  • Principal Investigator: Carlos Calderas, MD, Policlinica Metropolitana - Venezuela

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.
December 15, 2020

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.
March 13, 2023

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.
March 13, 2023

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).
October 5, 2020

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 12, 2020

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 14, 2020

Study Record Updates

Last Update Posted (Estimated)

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.
November 22, 2023

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.
November 20, 2023

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.
November 1, 2023

More Information

Terms related to this study

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.
  • CLP-05-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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