Clinical Trial Search

Primary: H01: All Cause Mortality — 244; 218 participants — p=0.12

Primary: Number of Participants Who Experienced Adverse Events Possibly Related to Study Intervention — 0; 6 Participants

Primary: Patient Survival at Day-30 Post Transplant and Absence of Severe Primary Heart Graft Dysfunction in the First 24 Hours Post-transplantation — 66 Participants — p=<0.0001

Primary: Short-term End Point — 61; 77 participants

Primary: Cardiac Index — 3.39; 3.42; 3.23 L/min/m2

Primary: Chest Tube Losses — 726; 781 millilters — p=<0.1

Primary: Patient Survival at Day 30 Post-transplantation and Absence of Severe PGD (Left or Right Ventricle) in the First 24 Hours Post-transplantation — 72 Participants

Primary: Technical Success (Graft Patency) in a MICS Approach — 100 percentage of grafts

Primary: Incidence of First MACE During Active Follow-up Period. — 80; 89 Participants — p=0.47

Primary: Proportion of Patients With Hospital Length of Stay Greater Than 7 Days. — 20; 16 Participants

Primary: Intraoperative Systemic Oxidative Damage — 69; 83 pg/ml

Primary: Number of Major Adverse Cardiac Events (MACE) — 9; 6; 2; 119 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: Major Adverse Coronary and Cerebrovascular Events (MACCE) — 0.130; 0.111 MACCE Event Rate per Person-Year

Primary: Major Adverse Cardiac and Cerebrovascular Event (MACCE) — 23; 10; 3; 1 participants — p=0.80

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

Primary: Patient Survival — 75 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: Intubation Time — 7; 9 hours

Primary: Myocardial Defect Perfusion — 15.76; 15.38; 2.08; 3.85 Percentage of Myocardial Perfusion

Primary: Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months — 128 Participants — p=0.0003

Primary: Number of Patients With Post-operative Combined Endpoint (i.e. With One or More of the Following) — 13; 26 participants

Primary: Number of Participants With Procedure Success, Measured at Exit From the Catheterization Laboratory — 28 participants

Primary: Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI) — 49.6; 46.1 ml per square meter — p=0.61

Primary: Septal Thickness Measured Before Cardiopulmonary Bypass — 22.9; 22.5 millimeters

Primary: Exercise Capacity Assessed as Peak Oxygen Consumption at 4 Weeks After Randomisation — 0.92; 0.87 mL/Kg/minute — p=0.63

Primary: Myocardial Protection Against Ischemic Injury — 298; 231 pg/ml

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

Primary: Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure — 100 percentage of participants

Primary: Amount of Postoperative Bleeding — 868.9; 1467.6 mL