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 December 2013 by UMC Utrecht
Sponsor:
Information provided by (Responsible Party):
Pierfrancesco Agostoni, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01982032
First received: August 27, 2013
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

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 Intervention
Periprosthetic Aortic Valve Regurgitation After TAVR
Procedure: Transcatheter aortic valve replacement
Device: Medtronic CoreValve system
Device: Edwards SAPIEN bioprosthesis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with 3DTEE [ Time Frame: Within 5 days after TAVR ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 108
Study Start Date: November 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01982032

Contacts
Contact: Pierfrancesco Agostoni, MD, PhD 0031887556167 p.agostoni@umcutrecht.nl

Locations
Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Pierfrancesco Agostoni, MD, PhD    0031887556167    p.agostoni@umcutrecht.nl   
Contact: Mariam Samim, MD    0031887559497    m.samim@umcutrecht.nl   
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Pierfrancesco Agostoni, MD, PhD UMC Utrecht
Study Chair: Pieter Stella, MD, PhD UMC Utrecht
Study Director: Mariam Samim, MD UMC Utrecht
  More Information

No publications provided

Responsible Party: Pierfrancesco Agostoni, Interventional Cardiologist, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01982032     History of Changes
Other Study ID Numbers: NL43116.041.13
Study First Received: August 27, 2013
Last Updated: December 30, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
Periprosthetic aortic valve regurgitation
3D transesophageal echocardiography
Cardiac MRI

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014