Valvular heart disease
Conditions
Interventions
Group 1: 120 Patients with heart valve pathology, who are planned for minimally invasive or open valve repair or replacement surgery will be included in this study with respect to the inclusion and ex
Sponsors
Universitätsklinikum Bonn
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patients with heart valve pathology and indication for valve repair or replacement surgery • This surgery can be a minimally invasive surgery or conventional • 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 • Surgery may be combined or isolated procedure
Exclusion criteria
Exclusion criteria: • Patients who did not sign the informed consent form and/ or refuse to participate • Patients unable to read or understand the informed consent • Patients high risk for surgery (STS >4%) • Infective Endocarditis at time of surgery • Emergency surgery (surgery within the day of admission)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are: • “Device success”, meaning: - one COR-KNOT ® titanium fastener used for each suture - Fastener released -Sufficient hemostasis /sufficiently secured suture - adequate position of titanium fastener at the end of operation • Operative Times (skin-to-skin, cardiopulmonary bypass, aortic cross clamp, prosthesis implantation) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Functional Assessment: Postoperative echocardiographic assessment (i.e., valve gradient, paravalvular leak) • Operative, 30 day mortality • 30 day stroke, rehospitalization, and morbidity (AEs, SAEs) • TTE or TEE at 30 days | — |
Countries
Bosnia & Herzegovina, Germany, Serbia
Contacts
Public ContactMiriam Silaschi
Universitätsklinikum Bonn
Outcome results
None listed