I35.0
Conditions
Interventions
Group 1: After successful screening process, the patient receives a percutaneous transluminal valvuloplasty of the aortic/pulmonary valve through the SimValve Force PTV catheter. The efficacy and safe
Sponsors
Simeks Tibbi Urunler San. ve Tic. LTD STI
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - The patient must have been informed about the study and must have signed a written consent to participate in the study - Patients with aortic or pulmonary valve stenosis for whom percutaneous transluminal valvuloplasty is planned - Patients with aortic or pulmonary valve stenosis for whom percutaneous transluminal valvuloplasty with implantation of a prosthetic heart valve is planned
Exclusion criteria
Exclusion criteria: - The patient must have been informed about the study and must have signed a written consent to participate in the study - Patients with aortic or pulmonary valve stenosis for whom percutaneous transluminal valvuloplasty is planned - Patients with aortic or pulmonary valve stenosis in whom percutaneous transluminal valvuloplasty with implantation of a prosthetic heart valve is planned - Known allergies to materials of individual components of the SimValve Force PTV catheter - Patients with mild valve stenosis - Moderate to severe aortic insufficiency - Patients with severe congenital heart defects requiring open heart surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of the procedure: The success of the procedure is determined by the procedure data from the catheter-based measurement of the transvalvular systolic peak pressure gradient of the aortic/pulmonary valve. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary endpoints existing | — |
Countries
Germany
Contacts
Public ContactMatti Adam
Universitätsklinikum Köln
Outcome results
None listed