Clinical Trial Search

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

Primary: Impaired Post-operative Functional Capacity — 35 Participants

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

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

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

Primary: All-cause Mortality — 2 Participants

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

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

Primary: Procedural Success — 42.86 Percentage of 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: Mitral Regurgitation Severity — 0.0; 0.0; 5.6; 38.9 Percentage of participants

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

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

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

Primary: 3D RVEF (Baseline) — 44.71; 48.74; 49.11 percentage — p=0.0167

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

Primary: Reduction in Leaflet Motion — 12 Participants

Primary: Change in Baseline Regurgitant Volume Associated With the Carillon Device Relative to the Control Population at 12 Months — -7.07; 3.32 ml/beat

Primary: Aortic Valve Mean Gradient (mm Hg) at Peak Exercise — 11; 14; 11 mm Hg

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: Intensity (Highness) of the Sound From Mechanical Heart Valves — 43; 41; 40 dB (decibel) — p=<0.05

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

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

Primary: Major Adverse Events (MAEs) — 9; 2; 0; 1 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: Primary Safety Endpoint: The Rate of All-cause Mortality, Disabling Stroke, Life-threatening Bleeding Requiring Blood Transfusion, Acute Kidney Injury (AKI) Requiring…

Primary: The Primary Endpoint is Technical Success — 17 Participants