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

Part of paid clinical trials in San Francisco, California.

Sponsor
Anteris Technologies Ltd.
Study ID
NCT07194265
Status
Recruiting
Apply to this trial

Conditions

  • Severe Aortic Stenosis
  • Valve-in-valve Procedures

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TAVR with DurAVR® THV — DEVICE
    Transcatheter aortic valve replacement (TAVR)
  • TAVR with SAPIEN THV series or the Evolut THV series — DEVICE
    Transcatheter aortic valve replacement (TAVR)

Study Details

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.

Key Dates

Start date
Oct 21, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Mar 31, 2038

Study Design

Enrollment
1,650 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DurAVR THV
    DurAVR® THV implantation
  • Active Comparator: Control
    SAPIEN THV series or the Evolut THV series implantation

Primary Outcome Measure

Composite of all-cause mortality, all stroke and cardiovascular hospitalization [ Time Frame: 1 Year ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Kaiser Permanente San FranciscoSan FranciscoCalifornia94118
Jacob Mishell, MD
[email protected]
415-202-3800
Montefiore Medical CenterThe BronxNew York10467
Andrea Scotti, MD
[email protected]
718-904-3442
The Stern Cardiovascular FoundationGermantownTennessee38138
Basil Paulus, MD
[email protected]
901-271-1000

Find similar trials in San Francisco, CA

By research site
Kaiser Permanente San Francisco· San Francisco, CAMontefiore Medical Center· The Bronx, NYThe Stern Cardiovascular Foundation· Germantown, TN

Related Studies