The STTAR-US Study: A Pivotal Study of Transcatheter Tricuspid Annular Repair in the US
NCT06700239 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600
Last updated 2025-11-26
Summary
Purpose of this clinical study is to demonstrate the safety and efficacy of MIA-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR grade ≥3) despite optimal medical therapy, who have been determined by the site's local heart team to be at intermediate or greater estimated risk for mortality and morbidity with tricuspid valve surgery.
Conditions
- Tricuspid Regurgitation Functional
- Tricuspid Regurgitation
- Severe Tricuspid Valve Regurgitation
Interventions
- DEVICE
-
MIA_T Device
MIA-T Device
Sponsors & Collaborators
-
Micro Interventional Devices
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-31
- Primary Completion
- 2027-06-30
- Completion
- 2032-12-31
- FDA Device
- Yes
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