Edwards SAPIEN-3 Periprosthetic Leakage Evaluation Versus Medtronic CoreValve in Transfemoral 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

TERMINATED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-05-31

Brief Summary

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Transcatheter aortic valve replacement (TAVR) is a good alternative treatment for patients with severe aortic valve stenosis with similar mid-term success rates as compared to surgery. Periprosthetic aortic regurgitation (PAR) after TAVR remains an important limitation of this technique. Moderate to severe PAR occurs in 15-45% of the cases and it is an independent predictor of mortality after TAVR. Little is known about potential differences in severity of PAR among different types of aortic valve prosthesis. The current randomized study aims to evaluate potential differences between the Edwards SAPIEN bioprosthesis and the Medtronic CoreValve® system with main focus on PAR and additional focus on other clinical and imaging endpoints. Primary objective of this study is to investigate the difference in the severity of PAR, measured with 3-dimensional transesophageal echocardiography (3DTEE), between patients undergoing the implantation of the Edwards SAPIEN bioprosthesis versus patients receiving the Medtronic CoreValve® bioprosthesis. Secondary objectives of this study include: investigating the value of different imaging modalities in evaluating periprosthetic regurgitation after TAVR and studying the difference in clinical endpoints according to VARC-2 definitions and quality of life after TAVR between two available aortic valve prostheses.

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Detailed Description

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Conditions

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Periprosthetic Aortic Valve Regurgitation After TAVI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Edwards SAPIEN bioprosthesis

Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis

Group Type ACTIVE_COMPARATOR

Transcatheter aortic valve replacement

Intervention Type PROCEDURE

Transcatheter aortic valve replacement

Edwards SAPIEN bioprosthesis

Intervention Type DEVICE

Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis

Medtronic CoreValve® system

Transcatheter aortic valve replacement with the Medtronic CoreValve system

Group Type ACTIVE_COMPARATOR

Transcatheter aortic valve replacement

Intervention Type PROCEDURE

Transcatheter aortic valve replacement

Medtronic CoreValve system

Intervention Type DEVICE

Transcatheter aortic valve replacement with the Medtronic CoreValve system

Interventions

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Transcatheter aortic valve replacement

Intervention Type PROCEDURE

Medtronic CoreValve system

Transcatheter aortic valve replacement with the Medtronic CoreValve system

Intervention Type DEVICE

Edwards SAPIEN bioprosthesis

Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

In order to be eligible to participate in this study, subjects must meet all of the following criteria:

* Patient is ≥18 years of age and diagnosed with severe symptomatic aortic stenosis, judged inoperable or at high surgical risk (EuroSCORE \> 15% or other criteria that make surgery high risk by a consensus among cardiologists and cardiac surgeons in the heart team) and deemed eligible for transfemoral-TAVI.
* Aortic annulus diameter ≥ 18 and ≤ 29 mm as assessed with MSCT.
* No contraindications to study requirements such as MRI or TEE.

Exclusion Criteria

* Patients unable or unwilling to give informed consent.
* Patients who are excluded from this study because of the size of their aortic annulus diameter.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No