Clinical Trial: Edwards SAPIEN Periprosthetic Leakage Evaluation Versus Medtronic CoreValve in Transfemoral Aortic Valve Implantation (the ELECT Trial)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title:

Brief 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.

Detailed Summary:
Sponsor: UMC Utrecht

Current Primary Outcome: PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with 3DTEE [ Time Frame: Within 5 days after TAVR ]

Original Primary Outcome: PAR (regurgitant volume [ml] and a regurgitant fraction [%]) after TAVR, as diagnosed with 3DTEE [ Time Frame: Within 5 days after TAVR ]

Current Secondary Outcome:

  • PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with cardiac magnetic resonance imaging [ Time Frame: Within 5 days after TAVR ]
  • PAR (expressed as regurgitant volume [ml]) 6 months after TAVR, as diagnosed with 3DTEE [ Time Frame: At 6 months +/- 2 weeks after TAVR ]
  • Clinical endpoints according to the VARC-2 [ Time Frame: 30 days ]
  • Quality of life, presented as scores of the short form 36 item health status survey (SF-36) and the Euroqol questionnaire (EQ-5D) [ Time Frame: 1 year ]


Original Secondary Outcome:

  • PAR (regurgitant volume [ml] and a regurgitant fraction [%]) after TAVR, as diagnosed with cardiac magnetic resonance imaging [ Time Frame: Within 5 days after TAVR ]
  • PAR (regurgitant volume [ml] and a regurgitant fraction [%]) 6 months after TAVR [ Time Frame: At 6 months +/- 2 weeks after TAVR ]
  • Clinical endpoints according to the VARC-2 [ Time Frame: 30 days ]
  • Quality of life, presented as scores of the short form 36 item health status survey (SF-36) and the Euroqol questionnaire (EQ-5D) [ Time Frame: 1 year ]


Information By: UMC Utrecht

Dates:
Date Received: August 27, 2013
Date Started: November 2013
Date Completion: November 2020
Last Updated: May 1, 2017
Last Verified: May 2017