Clinical Trial Search

Primary: Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE) — 3; 1 Participants

Primary: Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade — 71 Participants

Primary: Number of Participants Who Developed Infective Endocarditis — 9 participants

Primary: Percentage of Participants With Treatment Failure — 10.2; 3.9 percentage of participants

Primary: Impaired Post-operative Functional Capacity — 35 Participants

Primary: Procedural Success — 42.86 Percentage of Participants

Primary: Composite Major Adverse Event (MAE) Rate — 6 Participants

Primary: All-cause Mortality — 2 Participants

Primary: Late Adverse Event Rates — 1.90; 0; 2.61; 0.12 percentage of events/late patient years

Primary: Mean Gradient Across the Tricuspid Valve — 1.3; 2.0; 1.9 mmHg

Primary: Freedom From Device or Procedure Related Death or Reintervention — 97.1 percentage of participants

Primary: Change of EROA — 0.03; -0.05 square cm — p=<0.001

Primary: Change in the Degree of Tricuspid Regurgitation — 27; 18; 6; 6 participants

Primary: Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair — 7.1; 1.27; 0.21; 0.56 Percent occurrence per patient-year

Primary: Percentage of Participants With Freedom From Reoperation for Structural Valve Deterioration at 10 Years Post-Implant — 75.7 Percentage of Participants

Primary: Cardiac Death — 3.9; 3.8 percentage of participants with event

Primary: Endothelial Function Assessed by Flow Mediated Vasodilatation — 1.96; 1.73 EndoPAT index (EnFI)

Primary: The Primary Endpoint is Technical Success — 17 Participants

Primary: Late Adverse Event Incidence — 7; 0; 0; 4 event/100-patient years

Primary: Safety Endpoint: Number of Participants With Composite of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs) — 120 Participants

Primary: Technical Success at Exit From the Cath Lab. — 23; 20; 30 Participants

Primary: Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects — 2; 1; 2; 4 Participants

Primary: Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite) — 28 Participants

Primary: Mitral Regurgitation Severity — 0.0; 0.0; 5.6; 38.9 Percentage of participants

Primary: Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE — 10 Participants

Primary: Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI) — 54.6; 60.7 ml per square meter of body-surface area — p=0.18

Primary: Subject's Percentage of Long Term Safety Performance — 1.5; 2.7; 0.2; 0.4 Percentage of events/late patient years

Primary: Primary Safety Outcome Measure: Event-free Survival — 100 percentage of participants

Primary: Change From Baseline in Oxygen Consumption During Maximal Bike Exercise — 14.45; 14.18 mL/kg/min — p=0.823

Primary: Reduction in Leaflet Motion — 12 Participants