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

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.

Inclusion criteria

• Subject has severe functional TR (≥ 3). Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after any cardiac procedure(s)
• In the judgment of the site's local heart team patient is at intermediate or greater risk for morbidity & mortality with tricuspid valve surgery, and has been adequately treated per applicable standards with optimized medical therapy for the treatment of TR (e.g. diuretics) and stable for at least 30 days prior to enrollment.
• New York Heart Association (NYHA) Functional Class II, III or ambulatory class IV

Exclusion criteria

• Systolic pulmonary artery pressure (sPAP) > 70 mmHg or > 5 wood units (WU) despite vasodilator therapy
• Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mm Hg
• Previous tricuspid valve repair or replacement (transcatheter or surgical approach)
• Subjects with concomitant left-sided valve disease will have the option of receiving a left-sided intervention (e.g. TMVR or TAVR) and waiting 60 days prior to being reassessed for the study
• Myocardial infarction (MI), known unstable angina, symptomatic coronary artery disease (CAD) where revascularization is possible within 60 days prior to enrollment
• Anatomy that precludes safe placement of anchors around the annulus
• Hemodynamic instability defined as systolic pressure < 90 mmHg requiring pressor support within the last 30 days

Echo Criteria -

• Subject has severe functional TR (determined by the ICL). Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after any cardiac procedure(s)
• No presence of Cardiac Implantable Electronic Devices (CIED) leads causing the TR
• No significant annular calcification
• Left Ventricular Ejection Fraction (LVEF) ≥ 20%