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

November 6, 2018 updated by: Pieter Stella, UMC Utrecht

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Edwards SAPIEN bioprosthesis
Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis
Transcatheter aortic valve replacement
Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis
ACTIVE_COMPARATOR: Medtronic CoreValve® system
Transcatheter aortic valve replacement with the Medtronic CoreValve system
Transcatheter aortic valve replacement
Transcatheter aortic valve replacement with the Medtronic CoreValve system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 5 days after TAVR

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
PAR (expressed as regurgitant volume [ml]) 6 months after TAVR, as diagnosed with 3DTEE
At 6 months +/- 2 weeks after TAVR
Clinical endpoints according to the VARC-2
Time Frame: 30 days, 6months, 1 year
Clinical endpoints according to the VARC-2
30 days, 6months, 1 year
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)
1 year
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)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Pieter Stella, MD, PhD, UMC Utrecht
  • Study Chair: Pierfrancesco Agostoni, MD, PhD, UMC Utrecht
  • Study Director: Nynke Kooistra, MD, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2013

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (ESTIMATE)

November 13, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2018

Last Update Submitted That Met QC Criteria

November 6, 2018

Last Verified

November 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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