- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01982032
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
Status
Terminated
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
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-
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Utrecht, Netherlands, 3584 CX
- University Medical Center Utrecht
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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
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Transcatheter aortic valve replacement
Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis
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ACTIVE_COMPARATOR: Medtronic CoreValve® system
Transcatheter aortic valve replacement with the Medtronic CoreValve system
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Transcatheter aortic valve replacement
Transcatheter aortic valve replacement with the Medtronic CoreValve system
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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
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PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with 3DTEE
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Within 5 days after TAVR
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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
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Within 5 days after TAVR
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PAR (expressed as regurgitant volume [ml]) 6 months after TAVR, as diagnosed with 3DTEE
Time Frame: At 6 months +/- 2 weeks after TAVR
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PAR (expressed as regurgitant volume [ml]) 6 months after TAVR, as diagnosed with 3DTEE
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At 6 months +/- 2 weeks after TAVR
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Clinical endpoints according to the VARC-2
Time Frame: 30 days, 6months, 1 year
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Clinical endpoints according to the VARC-2
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30 days, 6months, 1 year
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Quality of life, presented as scores of the short form 36 item health status survey (SF-36)
Time Frame: 1 year
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Quality of life, presented as scores of the short form 36 item health status survey (SF-36)
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1 year
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Quality of life, according to the Euroqol questionnaire (EQ-5D)
Time Frame: 1 year
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Quality of life, presented as scores of the Euroqol questionnaire (EQ-5D)
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1 year
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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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL43116.041.13
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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