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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-05-31

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.

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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.

Conditions

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Aortic Valve Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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repositionable valve prosthesis

Lotus

Group Type EXPERIMENTAL

repositionable valve prosthesis

Intervention Type DEVICE

repositionable valve prosthesis implanted via trans-femoral and trans-catheter route

balloon-expandable valve prosthesis

Sapien

Group Type ACTIVE_COMPARATOR

balloon-expandable valve prosthesis

Intervention Type DEVICE

balloon-expandable valve prosthesis implanted via trans-femoral and trans-catheter route

Interventions

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repositionable valve prosthesis

repositionable valve prosthesis implanted via trans-femoral and trans-catheter route

Intervention Type DEVICE

balloon-expandable valve prosthesis

balloon-expandable valve prosthesis implanted via trans-femoral and trans-catheter route

Intervention Type DEVICE

Other Intervention Names

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Lotus Sapien

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No