aortic valve stenosis/insufficiency leakage of aortic valve
Conditions
Interventions
During and after the implant of the heartvalve (standaard medical preactice) a
transthoracic echocardiographic (TTE) assessment, physical examination
(including NYHA classification) and blood tests
Sponsors
Sorin Biomedica CRM SRL
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient with pre operative evaluation indicated the need for native or prosthetic aortic valve replacement. Any patient amenable to aortic valve replacement with biologcal prothesis, even in conjuction with valve repair, CABG and other procedures. Patient will be available to investigator for post-operative follow up beyond one year.
Exclusion criteria
Exclusion criteria: Patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position. Patient requires a double or triple valve replacement. Patient had previously implanted SOLO valve within th clinical study that requires replacement. Patient has major or progressive non-cardiac disease that, in the investigator's experience results in life expectancy of less than 1 year or the implant of the device produces an unacceptable increased risk to the patient. Patients with congenital bicuspid aortic valve. Patient has active endocarditis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate • the complication and survival rates for the SOLO valve are comparable to appropriate historical controls manifested as objective performance criteria (OPCs), and to that reported for other stentless bioprostheses and stented pericardial valves in the literature; • the hemodynamic performance of the SOLO valve is comparable to that reported in the literature for other stentless aortic bioprostheses and stented pericardial valves; and • clinically significant improvement in overall patient condition by comparison of preoperative and postoperative NYHA functional classifications. Outcomes: Safety endpoints: • Safety of the SOLO valve will be evaluated based on pre-determined adverse events related to cardiac valve replacement. Morbid events and valve-relatedness will be determined according to guidelines for reporting morbidity and mortality after valve surgery. Effectiveness endpoints: • Effectiveness of the SOLO valve will be determined by evaluation of hemodynamic performance to assess valve function and evaluation of NYHA classification to assess improvement in patient condition. | — |
Countries
Netherlands
Outcome results
None listed