Clinical Trial Search

Primary: Primary Composite Outcome: Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest…

Primary: 30-day Composite Major Adverse Cardiac Event (MACE) — 256; 83 participants

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

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

Primary: Subject's Average Time Spent on Cardiopulmonary Cross Clamp — 49.9; 65.2; 51.9 minutes

Primary: Acute Kidney Injury — 7; 41; 9; 40 participants — p=0.377

Primary: Enrollment and Randomization Feasibility — 40 Participants

Primary: Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System — 100 percentage of patients

Primary: Number of Patients With a Major Cardiac Implantable Electronic Devices (CIED) Infection — 5; 6 Participants

Primary: Number of Participants With In-hospital Death or Clinical Embolic Events — 9; 1 participants — p=<0.05

Primary: Postoperative Complications — 52; 72 numbers of complications

Primary: Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB) — -7.75; -10.94; 62.22 percent change…

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

Primary: Percentage of Participants With Interventional Procedures Successfully Completed — 10; 20 Participants

Primary: Myocardial Perfusion Reserve — 2.76; 2.47; 2.82; 2.52 Ratio

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

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

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

Primary: Stroke or Death in the Territory of Qualifying Artery — 5 Participants — p=0.08

Primary: Technical Success — 153 Participants

Primary: 888 Number of Participants With Major Adverse Cardiac Events (MACE) at 30 Days — 0 participants

Primary: Cumulative Volume of Packed Red Blood Cells Transfused — 1223.2; 623.5 mL — p=0.001

Primary: Death — 12 Participants

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

Primary: Subject's Average Time Spent on Cardiopulmonary Cross Clamp — 59.7 minutes

Primary: Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC) — 40; 14; 8; 18 Participants

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

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

Primary: Number of Participants With Device and Procedure Related Serious Adverse Events — 11; 5 Participants

Primary: Transcranial Doppler(TCD) Microembolic Signals During Surgical Aortic Valve Replacement Surgery — 354 units on a scale