Clinical Evaluation of a Modular Extracorporeal Circulation Circuit
Coronary Artery DiseaseAortic Valve Disease2 moreThe purpose of this clinical research study is the design of a novel modular hybrid system extracorporeal circulation circuit for open heart procedures that could easily be converted from a closed to a semi-closed circuit according to the indication. This could expand the potential of minimal extracorporeal circulation and could ultimately become the new standard circuit in performing every type of cardiac surgery.
Comparison of Two Pericardial Bioprostheses in AVR
Aortic Valve DiseaseThe purpose of the study is to compare early and 1-year hemodynamic performance and clinical outcomes after aortic valve replacement using two pericardial bioprosthesis, Avalus and Carpentier Edwards Perimount Magna Ease.
Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population...
Aortic Valve DiseaseThe objective of the study is to evaluate the safety information on the Perceval S sutureless prosthetic heart valve after the implantation for aortic valve disease. The study is designed as a post-market, observational, non-interventional retrospective and prospective registry.
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX
Coronary Artery DiseaseAortic Valve Disorder3 moreThe purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.
VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up (VITAL)...
Aortic Valve DiseaseAortic Valve StenosisThis study is an observational study to evaluate the long-term safety and effectiveness of the valve system.
Progel Vascular Sealant
Aortic Valve StenosisAneurysm of Ascending Aorta2 moreThis study is being conducted to evaluate the safety and effectiveness of the Progel Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
REpositionable Versus BallOOn-expandable Prosthesis for Trans-catheter Aortic Valve Implantation...
Aortic Valve DiseaseThere are different aortic valve prosthesis used for treatment of aortic valve disease through catheter-based procedures. The current study aims to compare two different aortic valve prosthesis regarding their outcomes at 30-day and 2-year follow-up.
Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)
Aortic Valve DiseaseSurgery--Complications1 moreThere is considerable morbidity and mortality associated with cardiac surgery. Currently little effort is made to quantify how well the immune system of an individual can cope with inflammation or infection to which they are exposed during surgery. The investigators have previously demonstrated that having higher pre-operative antibody levels is associated with a lower risk of infection and a shorter stay in hospital after cardiac surgery. The investigators aim to study 150 patients undergoing aortic valve replacement and explore their dynamic immune responsiveness. The investigators will determine if this response is correlated with the post-operative outcome (development of post-operative infection or increased length of hospital stay). The investigators will compare this response with the previously measured static markers of immune competence and also with a novel device that may give a more rapid measure of dynamic immunity. The investigators will approach patients in the cardiac surgical pre-assessment clinic to see if they are willing to participate in the study. Immediately once under anaesthetic blood will be taken for testing and then again at the end of surgery, 24h after surgery, at discharge from hospital, and at follow-up clinic approximately 4 weeks later. There will be no additional needle insertions on top of those routinely performed. The investigators will collect data from the routine observations as far as 1 year after surgery. If the investigators can show an association between immune function and subsequent post-operative outcome it may be possible to determine ways to improve outcomes for patients undergoing heart surgery. This might include better information on risks and benefits of surgery, actively boosting immune function (vaccination, immune-nutrition), passively improving immunity (administering antibodies), or consider current alternatives to open heart surgery where the threat of infection or inflammation may be markedly reduced (eg trans-catheter aortic valve implantation)
Early Initiation of Post Sternotomy CArdiac Rehabilitation
Coronary Artery DiseaseAortic Valve Disease1 moreThe main objective of this trial is to investigate the effects of starting exercise rehabilitation earlier than current practice after coronary artery bypass graft(CABG) or Aortic/Mitral valve replacement (VR) surgery.
EDWARDS INTUITY Valve System CADENCE-MIS Study
Aortic Valve DiseaseAortic StenosisThe study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.