DurAVR™ THV System: EMBARK Study

June 23, 2026 updated by: Anteris Technologies Ltd.

Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: First In Human Study (EMBARK Study)

A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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

The DurAVR™ THV System is a novel balloon-expandable single-piece 3D transcatheter aortic valve.

The study will enroll up to 150 subjects suffering from severe, symptomatic aortic stenosis as determined by a Heart Team. Subjects will be consented for follow-up to 1 year.

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 (Estimated)

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.
150

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 Locations

  • Georgia
      • Tbilisi, Georgia
        • Tbilisi Heart and Vascular Clinic LTD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Symptomatic, severe aortic stenosis
  2. Eligible for delivery of the DurAVR™ THV
  3. Anatomy appropriate to accommodate safe placement of DurAVR™ THV
  4. Understands the study requirements and the treatment procedures and provides written informed consent.
  5. Subject agrees to complete all required scheduled follow-up visits.

Exclusion Criteria:

Anatomical

  1. Anatomy precluding safe placement of DurAVR™ THV
  2. Pre-existing prosthetic heart valve in any position
  3. Unicuspid or bicuspid aortic valve
  4. Severe aortic regurgitation
  5. Severe mitral or severe tricuspid regurgitation requiring intervention
  6. Moderate to severe mitral stenosis
  7. Hypertrophic obstructive cardiomyopathy
  8. Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment
  9. Severe basal septal hypertrophy with outflow gradient Clinical
  10. Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment
  11. Determined inoperable/ineligible for surgery by the Heart Team
  12. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
  13. Blood dyscrasias as defined: leukopenia (WBC < 1000mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
  14. Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization
  15. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
  16. Need for emergency surgery for any reason
  17. Ventricular dysfunction with left ventricular ejection fraction (LVEF) ≤ 30% as measured by resting echocardiogram
  18. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
  19. Symptomatic carotid or vertebral artery disease
  20. End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min
  21. GI bleeding within the past 3 months
  22. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, nitinol (titanium or nickel), ticlopidine and clopidogrel, contrast media
  23. Ongoing sepsis, including active endocarditis
  24. Subject refuses a blood transfusion
  25. Life expectancy < 12 months due to associated non-cardiac co-morbid conditions
  26. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent
  27. Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
  28. Currently participating in an investigational drug or another investigational device trial
  29. Subject belongs to a vulnerable population.

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: Device Feasibility
  • 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: Treatment
DurAVR™ THV System
Device: DurAVR™ THV System
Transcatheter Aortic Valve Implantation (TAVI) 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
All-cause mortality
Time Frame: 30 days
All-cause mortality
30 days
DurAVR™ prosthetic heart valve implant
Time Frame: Immediate post procedure
Number of subjects for which a single DurAVR™ prosthetic heart valve was correctly positioned into the proper anatomical location
Immediate post procedure
Hemodynamic performance
Time Frame: Immediate post procedure
Effective Orifice Area (EOA), Mean gradient, Aortic Regurgitation, Paravalvular Leak (PVL), Doppler Velocity Index (DVI)
Immediate post procedure
All-cause mortality
Time Frame: 1 year
All-cause mortality
1 year
Myocardial infarction
Time Frame: 30 days
Myocardial infarction
30 days
Myocardial infarction
Time Frame: 1 year
Myocardial infarction
1 year
Stroke
Time Frame: 30 days
Disabling Stroke (VARC-3 Guidelines)
30 days
Stroke
Time Frame: 1 year
Disabling Stroke (VARC-3 Guidelines)
1 year
Life-threatening bleeding
Time Frame: 30 days
Life-threatening bleeding (VARC-3 Guidelines)
30 days
Life-threatening bleeding
Time Frame: 1 year
Life-threatening bleeding (VARC-3 Guidelines)
1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
DurAVR™ THV System ease of use
Time Frame: Intra-operative
DurAVR™ THV System ease of use (Questionnaire)
Intra-operative
Adverse Events
Time Frame: Throughout the entire study, up to 1 year.
VARC-3 defined adverse events
Throughout the entire study, up to 1 year.

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.
Anteris Technologies Ltd.

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.
  • Study Director: Chris Meduri, MD, Anteris Technologies

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.
November 15, 2021

Primary Completion (Estimated)

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.
January 1, 2028

Study Completion (Estimated)

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.
April 1, 2028

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).
December 6, 2021

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.
December 20, 2021

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.
January 10, 2022

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.
June 26, 2026

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.
June 23, 2026

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.
June 1, 2026

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.
  • SP0011

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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