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NCT05712161 · ClinicalTrials.gov registry record · NA
Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study
A NA study of Aortic Stenosis and Symptomatic Aortic Stenosis, sponsored by Anteris Technologies.
- Active
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 5
- Study locations
NCT05712161: Active NA study of Aortic Stenosis and Symptomatic Aortic Stenosis, sponsored by Anteris Technologies.
NCT05712161 is a NA study of Aortic Stenosis and Symptomatic Aortic Stenosis that is active but no longer recruiting, run by Anteris Technologies. The registered enrollment target is 15 participants, below the 1,362-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (99% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05712161, a NA study of Aortic Stenosis and Symptomatic Aortic Stenosis, is active but no longer recruiting, sponsored by Anteris Technologies.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 5
- Study locations
Study Summary
To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.
Primary Outcome
Mortality would be reported as rate of death/mortality at 30 days. Disabling stroke would be reported according to VARC-3 Guidelines
Conditions Studied
Interventions
- DEVICE DurAVRTM THV System
Study Locations (5)
New York
- Columbia University Medical Center/NYPH - New York
- Montefiore Medical Center - The Bronx
Arizona
- Tucson Medical Center - Tucson
Michigan
- University of Michigan - Ann Arbor
Ohio
- Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-08-07 |
| Est. Completion | 2033-12 |
| Phase | NA |
What the registry record for NCT05712161 still lists
NCT05712161 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,362-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Aortic Stenosis appearing as the primary indexed condition, and to 1 intervention - of which DurAVRTM THV System is the first listed.
NCT05712161 lists 5 locations in 4 states (New York, Arizona, Michigan).
Frequently Asked Questions
What is clinical trial NCT05712161 about?
NCT05712161 is a clinical study titled "Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study". To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.
What is the current status of trial NCT05712161?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2023-08-07. Estimated completion is 2033-12.
What conditions does trial NCT05712161 study?
This clinical trial studies the following conditions: Aortic Stenosis, Symptomatic Aortic Stenosis, Aortic Valve Calcification, Severe Aortic Valve Stenosis.
What interventions are being tested in trial NCT05712161?
The interventions under investigation include: DurAVRTM THV System (DEVICE).
Who is sponsoring clinical trial NCT05712161?
This trial is sponsored by Anteris Technologies, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05712161 being conducted?
This trial has 5 study locations across Arizona, Michigan, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Aortic Stenosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05712161's enrollment target sits among peer trials
15 24th of 26 higher than 3 of 26 other Aortic Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Stenosis 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.
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