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
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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 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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Edwards SAPIEN bioprosthesis
Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis
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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 |
- 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
- 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
- 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
- Clinical endpoints according to the VARC-2 [ Time Frame: 30 days, 6months, 1 year ]Clinical endpoints according to the VARC-2
- 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)
- 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)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Netherlands | |
University Medical Center Utrecht | |
Utrecht, Netherlands, 3584 CX |
Principal Investigator: | Pieter Stella, MD, PhD | UMC Utrecht | |
Study Chair: | Pierfrancesco Agostoni, MD, PhD | UMC Utrecht | |
Study Director: | Nynke Kooistra, MD | UMC Utrecht |
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 |
Periprosthetic aortic valve regurgitation 3D transesophageal echocardiography Cardiac MRI |
Aortic Valve Insufficiency Aortic Valve Disease Heart Valve Diseases Heart Diseases Cardiovascular Diseases |