A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Recruiting
N/A
Interventional Study
Severe Aortic Stenosis
Valve-in-valve Procedures
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,650 (estimated)
- Sponsor
- Anteris Technologies Ltd. · Industry
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About This Trial
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 commercial…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Native Aortic Stenosis Cohorts:
1. The subject is a candidate for TAVR using the DurAVR® THV System, and a SAPIEN series THV system or an Evolut series THV System.
2. The local Heart Team agrees that the subject has an appropriate indication for, and will benefit from, TAVR due…
Contacts