A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System

NCT07194265 | Recruiting DMC FDA Device

• 1 other identifier: SP0083
• Study Type: interventional
• Target: 1,650
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic Valve Replacement (TAVR), will be enrolled in the 'All Comers Randomized Cohort'. Subjects will be randomized 1:1 to receive either the DurAVR® THV System or any commercially available and approved Transcatheter Heart Valve (THV) from the SAPIEN series or the Evolut series and followed for 10 years. After completion of the All Comers Randomized Cohort, up to 446 additional low-risk subjects will be randomized 1:1 in the 'Low Risk Randomized Continued Access Cohort'. Up to 150 subjects with a failed surgical bioprosthesis who are deemed high surgical risk and who need valve-in-valve (ViV) TAVR will be enrolled in a separate nested registry (ViV Registry Cohort) and followed for 5 years. Subjects in the ViV Registry Cohort will only receive the DurAVR® THV.

Conditions

Severe Aortic Stenosis; Valve-in-valve Procedures

Keywords

tavr; severe calcific aortic stenosis; failed surgical bioprosthesis

Outcome Measures

Primary Outcomes (1)

• Composite of all-cause mortality, all stroke and cardiovascular hospitalization

  Composite of all-cause mortality, all stroke and cardiovascular hospitalization

  1 Year

Secondary Outcomes (5)

• All-cause mortality

  30 Days

• Disabling stroke according to VARC-3 Guidelines

  30 Days

• Life-threatening bleeding according to VARC-3 Guidelines

  30 Days

• Major vascular complication according to VARC-3 Guidelines

  30 Days

• Acute Kidney Injury (Stage III or IV) according to VARC-3 Guidelines

  30 Days

Other Outcomes (8)

• Mean Aortic Valve (AV) Gradient

  30 Days and 1 Year

• Valve-related dysfunction requiring a repeat procedure

  30 Days and 1 Year

• Doppler Velocity Index (DVI)

  30 Days and 1 Year

Study Arms (2)

DurAVR THV

EXPERIMENTAL

DurAVR® THV implantation

Device: TAVR with DurAVR® THV

Control

ACTIVE COMPARATOR

SAPIEN THV series or the Evolut THV series implantation

Device: TAVR with SAPIEN THV series or the Evolut THV series

Interventions

TAVR with DurAVR® THV DEVICE

Transcatheter aortic valve replacement (TAVR)

DurAVR THV

TAVR with SAPIEN THV series or the Evolut THV series DEVICE

Transcatheter aortic valve replacement (TAVR)

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Native Aortic Stenosis Cohorts:
• The subject is a candidate for TAVR using the DurAVR® THV System, and a SAPIEN series THV system or an Evolut series THV System.
• The local Heart Team agrees that the subject has an appropriate indication for, and will benefit from, TAVR due to native calcific valve severe aortic stenosis.
• Subject understands the study requirements and the treatment procedure and provides written informed consent.
• ViV Registry Cohort:
• Severe degeneration of a surgically implanted aortic bioprosthetic valve.
• Subject requires aortic valve replacement and is high surgical risk and is indicated for TAVR Valve-in-Valve procedure as determined by the Heart Team.
• Subject understands the study requirements and the treatment procedure and provides written informed consent.

You may not qualify if:

• Native Aortic Stenosis Cohorts:
• Native aortic annulus size unsuitable for study THVs (investigational or control) based on CT imaging analysis.
• Access vessel characteristics that would preclude safe placement of the introducer sheath (investigational or control).
• Evidence of an acute myocardial infarction 30 days before randomization.
• AV is unicuspid, Type 0 bicuspid, or is non-calcified.
• Severe total aortic regurgitation
• Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis.
• Pre-existing mechanical or bioprosthetic valve in any position.
• Untreated clinically significant coronary artery disease (CAD) requiring revascularization.
• Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation.
• Active bacterial endocarditis in the last 3 months.
• Estimated life expectancy (after TAVR) \<12 months.
• Subject is not a candidate for both arms (investigational and control) of the study.
• Subject belongs to a vulnerable population
• ViV Registry Cohort:

Sponsors & Collaborators

• Anteris Technologies Ltd.: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Capital Region of Denmark, 2100, Denmark

RECRUITING

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

Central Study Contacts

Jennifer Englund

CONTACT

612 895 5257; JEnglund@anteristech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized 1:1 to receive either TAVR using the DurAVR® THV System or TAVR using any commercially available and approved THV from the SAPIEN series or the Evolut series in the "All Comers Randomized Cohort"

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 26, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2038
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)