NCT01982032

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Periprosthetic Aortic Valve Regurgitation After TAVI

Interventions

Type	Name	Description
PROCEDURE	Transcatheter aortic valve replacement	Transcatheter aortic valve replacement
DEVICE	Medtronic CoreValve system	Transcatheter aortic valve replacement with the Medtronic CoreValve system
DEVICE	Edwards SAPIEN bioprosthesis	Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-05-01
• Completion: 2017-05-01
• First posted: 2013-11-13
• Last updated: 2018-11-08

Locations

1 site across 1 country: Netherlands