Nieheim

Researchers are evaluating the safety and performance of the AltaValve System for treating moderate-to-severe or severe mitral regurgitation in patients who are not suitable for surgery or other catheter-based repair methods. This prospective, single-arm, multicenter clinical trial focuses on two patient groups those with and without moderate to severe mitral annular calcification MAC. Participants will receive the AltaValve System, a transcatheter mitral valve replacement device designed to improve heart valve function. The study includes two cohorts based on the presence of MAC. The trial assesses outcomes such as all-cause mortality, heart failure hospitalizations, valve function, and quality of life over a long period extending up to five years after implantation. During the study, participants undergo various evaluations including mortality and stroke monitoring, kidney function tests, bleeding assessments, and technical success of the device. Quality of life and exercise capacity are measured using questionnaires and walk tests at 6 months and 1 year. Follow-up includes monitoring for pacemaker use and any need for additional valve interventions. The primary outcome is a composite measure of death or heart failure hospitalization within 12 months, with continued assessments up to 5 years.

Researchers are studying patients with coronary artery disease undergoing primary isolated non-emergency coronary artery bypass surgery CABG. The trial compares the use of a single arterial graft versus multiple arterial grafts to assess whether multiple grafts reduce the combined risk of death, stroke, heart attack after discharge, and repeat revascularization, as well as improve overall survival. This international randomized trial involves over 4,300 patients across at least 25 centers and aims to provide clear evidence on the benefits of arterial graft strategies in heart surgery. Participants will be randomly assigned to one of two groups. The first group receives a single arterial graft using the left internal thoracic artery, supplemented by venous grafts as needed. The second group receives multiple arterial grafts, including the left internal thoracic artery plus either the right internal thoracic artery or the radial artery, with the possibility of additional arterial grafts. Treatment is delivered during CABG surgery, and patients are followed over time to observe outcomes. During the study, participants will be monitored for major events such as death, stroke, heart attacks, and the need for additional procedures. Researchers will track these primary outcomes starting 72 hours after surgery and also evaluate secondary outcomes like 30-day mortality, postoperative complications, wound healing, stroke, cause-specific deaths, and hospital readmissions over a follow-up period that may average five years. The trial uses a randomized design to fairly compare the two grafting approaches and includes detailed safety and outcome assessments throughout the study period.