heart valve disease
Conditions
Interventions
None listed
Sponsors
Sorin Biomedica Cardio s.r.l.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Patients are male or female 18 years old or older; * Patients are willing to sign the informed consent; * Patients which preoperative evaluation indicated the need for native aortic valve replacement; * A bioprosthesis is the most suitable alternative for replacement of a dysfunctional or diseased native aortic valve according to the current medical practice for valve selection at the centre.
Exclusion criteria
Exclusion criteria: * Patients with severe evolving systemic diseases which could compromise the regular control visits or determine life expectancy minor than the duration of the study; * Patients with ejection fraction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| morbidity and mortality at 3 and 12 month follow-up after aortic valve replacement | — |
Secondary
| Measure | Time frame |
|---|---|
| - NYHA class at 3 and 12 month follow-up after aortic valve replacement; - echocardiographic parameters (EOA, MPG, PPG) at preoperative time, 3 and 12 months after aortic valve replacement - Evaluation of suturing time of the Freedom SOLO. | — |
Countries
Netherlands
Outcome results
None listed