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

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ClinicalTrials.gov Identifier: NCT01982032
Recruitment Status : Terminated (slow enrollment, study device unavailable ( CoreValve))
First Posted : November 13, 2013
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Pieter Stella, UMC Utrecht

August 27, 2013
November 13, 2013
November 8, 2018
November 2013
May 2016   (Final data collection date for primary outcome measure)
PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with 3DTEE [ Time Frame: Within 5 days after TAVR ]
PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with 3DTEE
PAR (regurgitant volume [ml] and a regurgitant fraction [%]) after TAVR, as diagnosed with 3DTEE [ Time Frame: Within 5 days after TAVR ]
Complete list of historical versions of study NCT01982032 on ClinicalTrials.gov Archive Site
  • 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]) after TAVR, as diagnosed with cardiac magnetic resonance imaging
  • PAR (expressed as regurgitant volume [ml]) 6 months after TAVR, as diagnosed with 3DTEE [ Time Frame: At 6 months +/- 2 weeks after TAVR ]
    PAR (expressed as regurgitant volume [ml]) 6 months after TAVR, as diagnosed with 3DTEE
  • Clinical endpoints according to the VARC-2 [ Time Frame: 30 days, 6months, 1 year ]
    Clinical endpoints according to the VARC-2
  • Quality of life, presented as scores of the short form 36 item health status survey (SF-36) [ Time Frame: 1 year ]
    Quality of life, presented as scores of the short form 36 item health status survey (SF-36)
  • Quality of life, according to the Euroqol questionnaire (EQ-5D) [ Time Frame: 1 year ]
    Quality of life, presented as scores of the Euroqol questionnaire (EQ-5D)
  • 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 ]
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Periprosthetic Aortic Valve Regurgitation After TAVI
  • 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
  • Active Comparator: Edwards SAPIEN bioprosthesis
    Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis
    Interventions:
    • Procedure: Transcatheter aortic valve replacement
    • Device: Edwards SAPIEN bioprosthesis
  • Active Comparator: Medtronic CoreValve® system
    Transcatheter aortic valve replacement with the Medtronic CoreValve system
    Interventions:
    • Procedure: Transcatheter aortic valve replacement
    • Device: Medtronic CoreValve system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
56
108
May 2017
May 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01982032
NL43116.041.13
Yes
Not Provided
Not Provided
Pieter Stella, UMC Utrecht
UMC Utrecht
Not Provided
Principal Investigator: Pieter Stella, MD, PhD UMC Utrecht
Study Chair: Pierfrancesco Agostoni, MD, PhD UMC Utrecht
Study Director: Nynke Kooistra, MD UMC Utrecht
UMC Utrecht
November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP