Edwards SAPIEN-3 Periprosthetic Leakage Evaluation Versus Medtronic CoreValve in Transfemoral Aortic Valve Implantation (ELECT)

UMC Utrecht

Status: Terminated

Conditions: Periprosthetic Aortic Valve Regurgitation After TAVI

Treatments: Procedure: Transcatheter aortic valve replacement; Device: Edwards SAPIEN bioprosthesis; Device: Medtronic CoreValve system

Study type: Interventional

Funder types: Other

Identifiers

NCT01982032

NL43116.041.13

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Edwards SAPIEN bioprosthesis

Active Comparator group

Description:

Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis

Treatment:

Device: Edwards SAPIEN bioprosthesis

Procedure: Transcatheter aortic valve replacement

Medtronic CoreValve® system

Active Comparator group

Description:

Transcatheter aortic valve replacement with the Medtronic CoreValve system

Treatment:

Device: Medtronic CoreValve system

Procedure: Transcatheter aortic valve replacement