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NCT07194265 · ClinicalTrials.gov registry record · NA
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
A NA study, sponsored by Anteris Technologies.
- Recruiting
- Registry status
- NA
- Development phase
- 1,650
- Enrollment target
NCT07194265 is a NA study that is actively recruiting participants, run by Anteris Technologies. The registered enrollment target is 1,650 participants.
The verdict
NCT07194265, a NA study, is actively recruiting participants, sponsored by Anteris Technologies.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,650 participants
- Enrollment target
Study 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.
Interventions
- DEVICE TAVR with DurAVR® THV
- DEVICE TAVR with SAPIEN THV series or the Evolut THV series
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,650 participants |
| Start Date | 2025-10-21 |
| Est. Completion | 2038-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07194265
The ClinicalTrials.gov registry entry for NCT07194265 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 1,650 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Anteris Technologies, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TAVR with DurAVR® THV is the first listed.
NCT07194265 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07194265 about?
NCT07194265 is a clinical study titled "A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System". 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...
What is the current status of trial NCT07194265?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,650 participants. The study started on 2025-10-21. Estimated completion is 2038-03.
What interventions are being tested in trial NCT07194265?
The interventions under investigation include: TAVR with DurAVR® THV (DEVICE), TAVR with SAPIEN THV series or the Evolut THV series (DEVICE).
Who is sponsoring clinical trial NCT07194265?
This trial is sponsored by Anteris Technologies, which has 2 total clinical trials registered on ClinicalTrials.gov.
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