Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study

NCT05712161 | Active Not Recruiting DMC FDA Device

• 1 other identifier: SP0028
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

Brief Summary

To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.

Conditions

Symptomatic Aortic Stenosis; Severe Aortic Valve Stenosis; Aortic Valve Calcification; Aortic Stenosis

Keywords

TAVI; TAVR; Transcatheter Valve; Transcatheter Aortic Valve Implantation

Outcome Measures

Primary Outcomes (2)

• All-cause mortality or disabling stroke

  Mortality would be reported as rate of death/mortality at 30 days. Disabling stroke would be reported according to VARC-3 Guidelines

  30days

• Technical success

  Freedom from mortality, successful device implant, and freedom from surgery or intervention related to the device.

  Immediate post procedure

Secondary Outcomes (8)

• All-cause mortality

  30days

• Disabling stroke

  30days

• Major vascular, access-related, or cardiac structural complication

  30days

• VARC-3 Type 2-4 bleeding

  30days

• Acute Kidney Injury stage 3 or 4

  30days

Other Outcomes (2)

• Hospitalization (or re-hospitalization)

  1 year

• Leaflet thickening and reduced motion

  1year

Study Arms (1)

DurAVR™ THV System

EXPERIMENTAL

TAVR procedure

Device: DurAVRTM THV System

Interventions

DurAVRTM THV System DEVICE

The DurAVR™ Transcatheter Heart Valve (THV) is a balloon expandable transcatheter aortic valve

DurAVR™ THV System

Eligibility Criteria

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

You may qualify if:

• Subjects are eligible for entry in this study if ALL the following conditions are met:
• Symptomatic, severe native aortic stenosis in subjects 65 years or older
• Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team (composed of an experienced interventional cardiologist and an experienced cardiac surgeon)
• Eligible for transfemoral delivery of the DurAVR™ THV
• Anatomy appropriate to accommodate safe placement of DurAVR™ THV (Preprocedural measurements by TTE and CT required: aortic annulus diameter 21-23 mm by CT)
• 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:

• Subjects are eligible for entry in this study if NONE of the following conditions are met:
• 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

Sponsors & Collaborators

• Anteris Technologies Ltd.: lead

Study Sites (5)

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve, Calcification of

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Reardon, MD

  Methodist DeBakey Hospital

  STUDY CHAIR

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

Model Details: A prospective, non-randomized, single-arm, multi-center study

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 3, 2023
• Study Start: August 7, 2023
• Primary Completion: December 29, 2023
• Study Completion (Estimated): December 1, 2033
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)