REpositionable Versus BallOOn-expandable Prosthesis for Trans-catheter Aortic Valve Implantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Comparison of Repositionable and Balloon-Expandable Prostheses in Patients Undergoing Trans-catheter Aortic Valve Implantation

Conditions
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Aortic Valve Disease

Intervention / Treatment
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* Device: repositionable valve prosthesis
* Device: balloon-expandable valve prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic aortic valve disease in need of valve replacement Heart team (including at least a cardiac surgeon and an interventional cardiologist) agrees on the eligibility that trans-femoral TAVI is appropriate. Study patient is an adult of legal consent age. Study patient has provided written informed consent to participate in the study Exclusion Criteria: Life expectancy < 12 months due to co-morbid conditions. Native aortic valve annulus size and morphology not suitable for Lotus or Sapien prosthesis implantation Preexisting bioprosthetic valve or ring in aortic valve position. Pre-existing pacemaker or ICD/CRT. Cardiogenic shock or hemodynamic instability. History of active endocarditis Contraindications for a trans-femoral access. Severe left ventricular dysfunction with LVEF <30%. Severe mitral valve insufficiency. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. Patients actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period. Patients suffering from dementia. Pregnant or nursing women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: repositionable valve prosthesis<br>Lotus | Device: repositionable valve prosthesis<br>* repositionable valve prosthesis implanted via trans-femoral and trans-catheter route<br>* Other names: Lotus;|
| Active Comparator: balloon-expandable valve prosthesis<br>Sapien | Device: balloon-expandable valve prosthesis<br>* balloon-expandable valve prosthesis implanted via trans-femoral and trans-catheter route<br>* Other names: Sapien;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of new permanent pacemaker implantation | implantation of PM | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of any prosthesis regurgitation | prosthesis regurgitation in echocardiography | 30 days | 
| Incidence of any conduction abnormalities | conduction abnormalities on rest ECG | 30 days | 
| Device success rate according to VARC-2 definition | combined endpoint | 30 days | 
| Mortality rate | all-cause death | 30 days | 
| Mortality rate | all-cause death | 1 year | 
| Mortality rate | all-cause death | 2 years | 
| incidence of early safety parameters according to VARC-2 definitions | combined endpoint | 30 days | 
| incidence of combined efficacy according to VARC-2 definitions | combined endpoint | 1 year | 
| incidence of combined efficacy according to VARC-2 definitions | combined endpoint | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, trans-femoral, Sapien, Lotus