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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: Recruiting NA study, sponsored by Anteris Technologies.
NCT07194265 is a NA study that is actively recruiting participants, run by Anteris Technologies. The registered enrollment target is 1,650 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (18% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT07194265 shows while recruiting
NCT07194265 is an interventional study that assigns participants to a tested intervention. Its 1,650 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (18% higher).
The record links to 0 conditions, and to 2 interventions - of which TAVR with DurAVR® THV is the first listed.
NCT07194265 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07194265's enrollment target sits among peer trials
1,650 62nd of 2000 higher than 1,938 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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