NCT05182307

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2021

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

3.1 years

First QC Date

December 6, 2021

Last Update Submit

January 30, 2024

Conditions

Symptomatic Aortic StenosisSevere Aortic Valve StenosisAortic Valve Calcification

Keywords

TAVITAVRTranscatheter Aortic Valve ImplantationTranscatheter valve

Outcome Measures

Primary Outcomes (10)

  • DurAVR™ prosthetic heart valve implant

    Number of subjects for which a single DurAVR™ prosthetic heart valve was correctly positioned into the proper anatomical location

    Immediate post procedure

  • Hemodynamic performance

    Effective Orifice Area (EOA), Mean gradient, Aortic Regurgitation, Paravalvular Leak (PVL), Doppler Velocity Index (DVI)

    Immediate post procedure

  • All-cause mortality

    All-cause mortality

    30 days

  • All-cause mortality

    All-cause mortality

    1 year

  • Myocardial infarction

    Myocardial infarction

    30 days

  • Myocardial infarction

    Myocardial infarction

    1 year

  • Stroke

    Disabling Stroke (VARC-3 Guidelines)

    30 days

  • Stroke

    Disabling Stroke (VARC-3 Guidelines)

    1 year

  • Life-threatening bleeding

    Life-threatening bleeding (VARC-3 Guidelines)

    30 days

  • Life-threatening bleeding

    Life-threatening bleeding (VARC-3 Guidelines)

    1 year

Other Outcomes (2)

  • DurAVR™ THV System ease of use

    Intra-operative

  • Adverse Events

    Throughout the entire study, up to 1 year.

Study Arms (1)

Treatment

EXPERIMENTAL

DurAVR™ THV System

Device: DurAVR™ THV System

Interventions

DurAVR™ THV SystemDEVICE

Transcatheter Aortic Valve Implantation (TAVI) Procedure

Treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Anatomical
  • Anatomy precluding safe placement of DurAVR™ THV
  • Pre-existing prosthetic heart valve in any position
  • Unicuspid or bicuspid aortic valve
  • Severe aortic regurgitation
  • Severe mitral or severe tricuspid regurgitation requiring intervention
  • Moderate to severe mitral stenosis
  • Hypertrophic obstructive cardiomyopathy
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment
  • Severe basal septal hypertrophy with outflow gradient Clinical
  • Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment
  • Determined inoperable/ineligible for surgery by the Heart Team
  • Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
  • Blood dyscrasias as defined: leukopenia (WBC \< 1000mm3), thrombocytopenia (platelet count \< 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
  • Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tbilisi Heart and Vascular Clinic Ltd

Tbilisi, Georgia

Location

MeSH Terms

Conditions

Aortic Valve StenosisAortic Valve, Calcification of

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Chris Meduri, MD

    Anteris Technologies

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 6, 2021

First Posted

January 10, 2022

Study Start

November 15, 2021

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

GE(1)