NCT06700239

The STTAR-US Study: A Pivotal Study of Transcatheter Tricuspid Annular Repair in the US

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Micro Interventional Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A prospective, multi-center, randomized, controlled, pivotal study of the MIA Percutaneous Tricuspid Annuloplasty System (MIA-T) in symptomatic subjects with severe (≥3) TR despite optimal medical therapy. The study will randomize eligible subjects in two (2) cohorts at up to 40 sites.

Conditions

• Tricuspid Regurgitation Functional
• Tricuspid Regurgitation
• Severe Tricuspid Valve Regurgitation

Interventions

Type	Name	Description
DEVICE	MIA_T Device	MIA-T Device

Timeline

• Start date: 2025-12-31
• Primary completion: 2027-06-01
• Completion: 2032-12-01
• First posted: 2024-11-21
• Last updated: 2025-11-26

Regulatory

• FDA-regulated device study