Aortic Valve Disease
Conditions
Keywords
TAVI, trans-femoral, Sapien, Lotus
Brief summary
There are different aortic valve prosthesis used for treatment of aortic valve disease through catheter-based procedures. The current study aims to compare two different aortic valve prosthesis regarding their outcomes at 30-day and 2-year follow-up.
Detailed description
Important improvements in aortic valve prostheses technology has been made aiming comparable performance of these prosthesis to surgical valve ones. The experience with the early generation of aortic valve prostheses revealed some important differences regarding the incidence of paravalvular leakage, need for pacemaker or valve thrombosis among them. Currently the new generations of valve prostheses such as Sapien 3 balloon-expandable valve and Lotus, repositionable valve are the most frequently used devices. There are registry data about the clinical performance of these valve types but a randomized comparison is missing.
Interventions
DEVICErepositionable valve prosthesis
repositionable valve prosthesis implanted via trans-femoral and trans-catheter route
DEVICEballoon-expandable valve prosthesis
balloon-expandable valve prosthesis implanted via trans-femoral and trans-catheter route
Sponsors
LMU Klinikum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Symptomatic aortic valve disease in need of valve replacement 2. Heart team (including at least a cardiac surgeon and an interventional cardiologist) agrees on the eligibility that trans-femoral TAVI is appropriate. 3. Study patient is an adult of legal consent age. 4. Study patient has provided written informed consent to participate in the study
Exclusion criteria
1. Life expectancy \< 12 months due to co-morbid conditions. 2. Native aortic valve annulus size and morphology not suitable for Lotus or Sapien prosthesis implantation 3. Preexisting bioprosthetic valve or ring in aortic valve position. 4. Pre-existing pacemaker or ICD/CRT. 5. Cardiogenic shock or hemodynamic instability. 6. History of active endocarditis 7. Contraindications for a trans-femoral access. 8. Severe left ventricular dysfunction with LVEF \<30%. 9. Severe mitral valve insufficiency. 10. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. 11. Patients actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period. 12. Patients suffering from dementia. 13. Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of new permanent pacemaker implantation | 30 days | implantation of PM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of any conduction abnormalities | 30 days | conduction abnormalities on rest ECG |
| Device success rate according to VARC-2 definition | 30 days | combined endpoint |
| incidence of any prosthesis regurgitation | 30 days | prosthesis regurgitation in echocardiography |
| incidence of early safety parameters according to VARC-2 definitions | 30 days | combined endpoint |
| incidence of combined efficacy according to VARC-2 definitions | 1 year | combined endpoint |
| Mortality rate | 30 days | all-cause death |
Countries
Germany, Italy
Outcome results
None listed