The STTAR-US Study: A Pivotal Study of Transcatheter Tricuspid Annular Repair in the US
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.
Subject has severe functional TR (≥ 3). Note: If any cardiac procedure(s) occur... [+2]
Systolic pulmonary artery pressure (sPAP) > 70 mmHg or > 5 wood units (WU) despi... [+10]