VIenna Pilot Study for Automated Annular Suturing Technology

VIenna Pilot Study for Automated Annular Suturing Technology to Assist in Aortic & Mitral Valve Replacement - A Single-center Clinical Safety & Feasibility Pilot Trial

The objective of this study is to compare surgical outcomes between patients who underwent valve replacement with and without the help of the automated annular suturing technology. In addition, data of the early and intermediate postoperative period will be collected within routine clinical follow-up in order to assess morbidity and mortality as well as echocardiographic parameters.

This study is a clinical, single-center pilot-study to evaluate safety and performance. 30 Patients (n=20 aortic valve replacement/ n=10 mitral valve replacement) with aortic and mitral valve pathology, highly likely for prosthetic valve replacement, who are planned for surgery at the Vienna General Hospital (AKH) will be included in this study with respect to the inclusion and exclusion criteria. The patients will undergo aortic or prosthetic mitral valve replacement using a specified automated annular suturing system for placement of the annular pledgeted sutures.

Inclusion Criteria:

• Patients with low to moderate operative risk (Defined by STS mortality risk below 8%)
• Patients above the age of 18 years
• Patients willing and able to sign the informed consent

Exclusion Criteria:

• Patients with active endocarditis
• Patients with previous cardiac surgery other than pacemaker implantation
• Emergency procedures
• Patient who did not sign the informed consent form and/ or refuse to participate
• Patients unable to read or understand the informed consent