Safety and Efficacy of the RENATUS® Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis
NCT07414342 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800
Last updated 2026-02-17
Summary
This study is a prospective, non-randomized, observational, post-market follow-up trial designed to evaluate the safety and efficacy of the RENATUS® Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
Conditions
- Severe Aortic Stenosis
Interventions
- DEVICE
-
RENATUS® TAVR
RENATUS® Transcatheter Aortic Valve System,an approved marketed TAVR
Sponsors & Collaborators
-
Beijing Balance Medical Technology Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 60 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-28
- Primary Completion
- 2027-09-30
- Completion
- 2037-09-30
Countries
- China
Study Locations
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