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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Periprosthetic Aortic Valve Regurgitation After TAVI Procedure: Transcatheter aortic valve replacement Device: Medtronic CoreValve system Device: Edwards SAPIEN bioprosthesis Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Edwards SAPIEN-3 Periprosthetic Leakage Evaluation Versus Medtronic CoreValve in Transfemoral Aortic Valve Implantation (ELECT) Trial
Actual Study Start Date : November 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2017
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Edwards SAPIEN bioprosthesis
Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis
 Procedure: Transcatheter aortic valve replacement
Transcatheter aortic valve replacement

Device: Edwards SAPIEN bioprosthesis
Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis
Active Comparator: Medtronic CoreValve® system
Transcatheter aortic valve replacement with the Medtronic CoreValve system
 Procedure: Transcatheter aortic valve replacement
Transcatheter aortic valve replacement

Device: Medtronic CoreValve system
Transcatheter aortic valve replacement with the Medtronic CoreValve system


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Clinical endpoints according to the VARC-2 [ Time Frame: 30 days, 6months, 1 year ]
    Clinical endpoints according to the VARC-2

  4. 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)

  5. 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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982032


Locations
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Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Investigators
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Principal Investigator: Pieter Stella, MD, PhD UMC Utrecht
Study Chair: Pierfrancesco Agostoni, MD, PhD UMC Utrecht
Study Director: Nynke Kooistra, MD UMC Utrecht
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pieter Stella, Interventional Cardiologist, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01982032    
Other Study ID Numbers: NL43116.041.13
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Keywords provided by Pieter Stella, UMC Utrecht:
Periprosthetic aortic valve regurgitation
3D transesophageal echocardiography
Cardiac MRI
Additional relevant MeSH terms:
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Aortic Valve Insufficiency
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases