Clinical Evaluation of a Modular Extracorporeal Circulation Circuit
Condition: Coronary Artery Disease; Aortic Valve Disease; Mitral Valve Disease; Aortic Aneurysm
MeSH terms: Coronary Artery Disease; Aneurysm; Aortic Aneurysm; Aortic Valve Disease
Study type: Interventional

Summary: 
      The 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.
    

Detailed description: 
      Development of cardiopulmonary bypass circuit (heart-lung machine) is considered as a
      landmark breakthrough in cardiac surgery, greatly promoting treatment of cardiovascular
      diseases. Since 1953, when the first operation under cardiopulmonary bypass was performed and
      for almost 6 decades, little progress has been made in the direction of improving
      cardiopulmonary bypass technology. However, evolution is feasible. The proposed research
      project challenges the traditional belief that conventional cardiopulmonary bypass should be
      considered as "state of the art" technology by deducting solid evidence towards extended use
      of the novel minimal extracorporeal circulation circuit, which is related to an improved
      outcome through multiple studies. Research methodology is based on analyzing laboratory and
      clinical data obtained through implementing the standard and the novel technology. In order
      to provide solid evidence on the comparative effectiveness of both therapies, it combines
      analysis of clinical and laboratory data with data related to cost and quality of life. Thus,
      it assesses novel technology from a global perspective and the evidence obtained would be
      considered robust.

      The ultimate purpose of the research proposal is the design of a modular hybrid system, that
      could easily convert from form a closed to a semi-closed circuit according to the indication,
      that could expand the potential of minimal extracorporeal circulation and could ultimately
      become the new standard circuit in performing every type of cardiac surgery. The term modular
      refers to an additionally mounted, clamped-off venous reservoir which allows to run the
      system as an open circuit in case of anticipated volume loss (ie bleeding, complex
      procedures, long bypass run). This measure follows the proverb 'always expect the unexpected'
      and offers the clinical practitioner an additional safety margin in case of unexpected
      intraoperative events. Unique design of this circuit would offer the opportunity of reducing
      cost, while at the same time improving clinical outcome. Preliminary design of this circuit,
      performed in our institution, is presented schematically in the appendix. After completion of
      the study protocol the designed circuit will be patented.

      Our institution has already performed extensive research and has gained international
      reputation as a training centre on minimal extracorporeal circulation. Design of such a
      circuit could promote further research funded by the medical industry. Considering the number
      of cardiac surgical procedures performed every day worldwide, this evolution is greatly
      ambitious and could be characterized as a major breakthrough in the field of cardiac surgery
      opening up new horizons in the field of cardiovascular research. It would also exert a
      positive effect on global healthcare affecting lives of millions of people suffering from
      cardiovascular disease.
    

Intervention name(s): Modular Cardiopulmonary Bypass Circuit
Intervention type(s): Device
Intervention description(s): Open heart surgery with a novel hybrid modular extracorporeal circulation circuit which is a closed cardiopulmonary bypass circuit with enhanced safety as it can be instantly converted to an open circuit.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Extracorporeal Circulation; Cardiopulmonary Bypass; Cardiac surgery