Clinical Trial Search

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

Primary: Incidence of Documented Post-operative Atrial Fibrillation — 17; 2 Participants

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

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

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

Primary: Numbers of Participants Free From AF — 20; 96; 20; 97 Participants

Primary: Primary Safety Endpoint — 3.9; 3.6 percentage of participants

Primary: Primary Safety Endpoint — 0; 0; 4.2; 0 percentage of participants

Primary: Efficacy Endpoint: The Percent of Patients Off Class I and/or III Antiarrhythmic Drugs and Out of Atrial Fibrillation as Determined by 24 Hour Holter Recording Conducted…

Primary: Intraoperative and Postoperative Transfusions — 2.43; 2.97; 4.42; 3.50 units of blood per participant — p=0.354

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

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

Primary: Acute Lung Injury After Cardiac Surgery — 20 participants — p=<0.05

Primary: Incidence of Postoperative Atrial Fibrillation — 5; 4; 5 participants

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

Primary: Efficacy Endpoint: The Percent of Patients Off Class I or III Antiarrhythmic Drugs and Out of AF as Determined by 24 Hour Holter Recording at 9 Months — 42.6 percentage…

Primary: Accuracy (FTF Decision on Patient Disposition vs. V-visit Decision on Patient Disposition) — 89 percentage of agreement

Primary: Time-based Score — 553; 127; 143 score on a scale

Primary: Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects — 2; 1; 2; 4 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: Postoperative Fentanyl — 4.51; 6.14 microgram/kilogram

Primary: ACTH and Cytokine Levels — 116.9; 182.7; 135.3; 44.5 pg/mL

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

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

Primary: Enrollment and Randomization Feasibility — 40 Participants

Primary: Freedom From Atrial Fibrillation — 31.1; 61.8 percentage of patients

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

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

Primary: Time to Hemostasis (TTH) — 1.50; 3.00 minutes