Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by UMC Utrecht
Sponsor:
Information provided by (Responsible Party):
Masieh Abawi, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01982032
First received: August 27, 2013
Last updated: February 22, 2015
Last verified: February 2015

August 27, 2013
February 22, 2015
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 ] [ Designated as safety issue: No ]
PAR (regurgitant volume [ml] and a regurgitant fraction [%]) after TAVR, as diagnosed with 3DTEE [ Time Frame: Within 5 days after TAVR ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • PAR (expressed as regurgitant volume [ml]) 6 months after TAVR, as diagnosed with 3DTEE [ Time Frame: At 6 months +/- 2 weeks after TAVR ] [ Designated as safety issue: No ]
  • Clinical endpoints according to the VARC-2 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • PAR (regurgitant volume [ml] and a regurgitant fraction [%]) after TAVR, as diagnosed with cardiac magnetic resonance imaging [ Time Frame: Within 5 days after TAVR ] [ Designated as safety issue: No ]
  • PAR (regurgitant volume [ml] and a regurgitant fraction [%]) 6 months after TAVR [ Time Frame: At 6 months +/- 2 weeks after TAVR ] [ Designated as safety issue: No ]
  • Clinical endpoints according to the VARC-2 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Edwards SAPIEN Periprosthetic Leakage Evaluation Versus Medtronic CoreValve in Transfemoral Aortic Valve Implantation (the ELECT Trial)
Not Provided

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 Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Periprosthetic Aortic Valve Regurgitation After TAVR
  • 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.
 
Recruiting
108
November 2017
May 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient is 18 years of age or older and diagnosed with severe symptomatic aortic stenosis, judged inoperable or at high surgical risk (EuroSCORE < 15%) and deemed eligible for TAVR by a consensus among a cardiologist and a cardiac surgeon (heart-team)
  • Or a patient who is considered to be operable by the heart-team, but who chooses to undergo TAVI instead of conventional surgery
  • Aortic annulus diameter ≥18 and ≤27 mm
  • Patients who undergo TAVR via the transfemoral approach

Exclusion Criteria:

  • Patients with contraindications for TEE will be excluded
  • Patients unable or unwilling to give informed consent
Both
18 Years and older
No
Contact: Masieh Abawi 0031887559497 m.abawi@umcutrecht.nl
Netherlands
 
NCT01982032
NL43116.041.13
Yes
Masieh Abawi, UMC Utrecht
UMC Utrecht
Not Provided
Principal Investigator: Pierfrancesco Agostoni, MD, PhD UMC Utrecht
Study Chair: Pieter Stella, MD, PhD UMC Utrecht
Study Director: Masieh Abawi UMC Utrecht
UMC Utrecht
February 2015

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