Clinical Trial Search

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

Primary: Number of Participants Who Developed Infective Endocarditis — 9 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: Percentage of MAE Free Subjects — 10 Participants

Primary: Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Rate — 0.099 probability of events at 30 days

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

Primary: Number of Participants With Major Vascular Complications — 2; 1 Participants

Primary: Reduction in Leaflet Motion — 12 Participants

Primary: Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier) — 88.2; 87.7 percentage of participants

Primary: Composite Major Adverse Event (MAE) Free Rate — 54.2; 48.1; 51.6 Percentage of subjects

Primary: Number of Deaths — 16 Participants

Primary: Primary Device Performance Endpoint: Mean Aortic Valve Pressure Gradient at 30 Days Post Implant Procedure — 11.45 mmHG

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

Primary: Percentage of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 1-year Post-implant. — 100.0 percentage of subjects

Primary: Percent of Early Adverse Events — 1.7; 1.0; 4.5; 0.0 Percentage of subjects

Primary: Number of Participants With Adverse Events — 6; 14; 53; 10 participants

Primary: Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort — 3.9; 0.9; 0.6; 0.3 Percentage of…

Primary: Median Subject Time Spent on Cardiopulmonary Cross Clamp — 35.0; 47.5 Minutes — p=<0.0001

Primary: (Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke — 0; 1; 59 Participants

Primary: Number of Deaths — 21 Participants

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

Primary: Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment — 0.6; 0.6 units on a scale

Primary: Procedural Success — 42.86 Percentage of Participants

Primary: Clinical Procedural Success — 9 participants

Primary: Improvement of the AVA and NYHA Functional Classification — 38.2; 45.8 % of participants

Primary: Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization — 105; 102 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: Late Adverse Event Rates — 1.90; 0; 2.61; 0.12 percentage of events/late patient years

Primary: All-cause Mortality Rate — 1.7 percentage of participants

Primary: Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint) — 94.8 Percentage of participants