aortic valve stenosis, aortic valve insuffciency
Conditions
Interventions
Group 1: Patients with aortic valve stenosis or insufficiency planned for minimally invasive aortic valve replacement. The patients will undergo surgery using a specified automated annular suturing sy
Sponsors
Klinik und Poliklinik für Herzchirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patients with aortic valve pathology and indication for surgical aortic valve replacement • Patients with low to moderate operative risk (Defined by STS mortality risk below 8%) • Left Ventricular Ejection Fraction > 35% • Life expectancy above 1 year based on operator assessment • Patients above the age of 18 years • Patients willing and able to sign the informed consent
Exclusion criteria
Exclusion criteria: • Patients with active endocarditis • Patients with previous cardiac surgery other than pacemaker implantation • Emergency procedures • Patients who did not sign the informed consent form and/ or refuse to participate • Patients unable to read or understand the informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedural times: - Skin-to-skin - extracorporal circulation time - aortic cross clamp time - prosthesis implantation time (i.e., from start of valve assessment until completion of implantation of the prosthesis) Functional assessment: - Postoperative hemodynamic performance (Echocardiographic measurement of trans-prosthetic gradients) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Mortality 30 days - Morbidity (AEs, SAEs) 30 days | — |
Countries
Germany
Contacts
Public ContactSonja Friese
Klinik und Poliklinik für Herzchirurgie
Outcome results
None listed