The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).
The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe. MPCs are normally present in human bone marrow and have been shown to increase the development of blood vessels and new heart muscle cells in the heart. In addition, this research is being done to test whether injecting the MPCs into the heart is effective in improving heart function.
To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).
To evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgery on cardiopulmonary bypass (CPB).
To assess the impact of the CytoSorb device during cardiopulmonary bypass compared to standard of care without CytoSorb. Measures include change in plasma free hemoglobin; assessment of device-related adverse events; time on ventilator; time in ICU; hospital stay; incidence of acute kidney injury; and others.
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
Low cardiac output syndrome (LCOs) is a serious complication in critically ill patients or those undergoing major surgery, resulting in multiple organ damage with significant in-hospital and long-term morbidity and mortality, as well as prolonged hospital stay. In this setting the mortality rate is distressingly high despite improvements in intensive care treatment, but survivors have an acceptable quality of life.
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their native or prosthetic mitral valve.
Congenital heart disease (CHD) is the most common birth defect with an incidence of 1 in 100 live births. Many cytogenetic abnormalities have been associated with CHD. Evidence is accumulating that many developmental defects can result from small genomic alterations invisible at the cytogenetic level, resulting in changes in copy number of contiguous genes. As a site in the National Heart, Lung, and Blood Institute-sponsored Pediatric Cardiac Genomics Consortium (PCGC) we will work to help elucidate the potential genetic causes of congenital heart disease. Our goal is to recruit 2000 fa
Long term follow up for CTOTC-04 patients and 2 year observational study looking at allo-antibodies in newly transplanted patients both sensitized and non sensitized.
