Patients who have undergone successful transcatheter bioprosthetic aortic valve implantation (TAVI)
Conditions
Brief summary
The number of patients with at least one prosthetic valve leaflet with HALT as assessed by cardiac CT at one year after TAVI.
Detailed description
The combined clinical endpoint of all-cause mortality, thromboembolic event, and life-threatening or major bleeding at 1 year, 3 years and 5 years after randomization, The number of patients with at least one prosthetic valve leaflet with HALT as assessed by cardiac CT at 3 months, 1, 3 and 5 years after TAVI, Number of prosthetic leaflets with HALT at CT-scan at 3 months, 1 year, 3 and 5 years., The clinical endpoint of ischemic stroke verified by cerebrovascular imaging after the TAVI-procedure in patients with vs. without HALT., Any type of stroke – including ischemic and hemorrhagic stroke, All-cause mortality, Cardiovascular mortality as defined in current VARC definition, Major bleeding or life-threatening bleeding, Need for re-intervention (valve-in-valve TAVI, paravalvular leak closure, SAVR), Aortic bioprosthetic dysfunction (according to EAPCI/ESC/EACTS definitions), Rate of bioprosthetic valve failure (according to EAPCI/ESC/EACTS definitions), NYHA classification, Quality of life scores
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients with at least one prosthetic valve leaflet with HALT as assessed by cardiac CT at one year after TAVI. | — |
Secondary
| Measure | Time frame |
|---|---|
| The combined clinical endpoint of all-cause mortality, thromboembolic event, and life-threatening or major bleeding at 1 year, 3 years and 5 years after randomization, The number of patients with at least one prosthetic valve leaflet with HALT as assessed by cardiac CT at 3 months, 1, 3 and 5 years after TAVI, Number of prosthetic leaflets with HALT at CT-scan at 3 months, 1 year, 3 and 5 years., The clinical endpoint of ischemic stroke verified by cerebrovascular imaging after the TAVI-procedure in patients with vs. without HALT., Any type of stroke – including ischemic and hemorrhagic stroke, All-cause mortality, Cardiovascular mortality as defined in current VARC definition, Major bleeding or life-threatening bleeding, Need for re-intervention (valve-in-valve TAVI, paravalvular leak closure, SAVR), Aortic bioprosthetic dysfunction (according to EAPCI/ESC/EACTS definitions), Rate of bioprosthetic valve failure (according to EAPCI/ESC/EACTS definitions), NYHA classification, Quality o | — |
Countries
Denmark