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 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
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
Parallel
MIA_T Device
DeviceMIA-T Device
Primary Efficacy Endpoint
Composite endpoint of the following components: * All-cause mortality * Tricuspid valve intervention (percutaneous or surgery) * Heart Failure Hospitalization
Primary Safety Endpoint
Freedom from MAE, including: * Cardiovascular mortality * New Onset Renal Failure * Endocarditis requiring surgery * Non-elective cardiovascular surgery for device-related AE post-index procedure
Freedom from all-cause mortality at all study timepoints
Freedom from heart failure hospitalizations at all study timepoints
Clinical Success Rate
Intraprocedural Success Rate
TR Grade Reduction
Change in TR grade to moderate or less
KCCQ Reduction
Average change in patients overall KCCQ summary scores by ≥ 10
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