Periprosthetic Aortic Valve Regurgitation After TAVIELECTNCT01982032
Edwards SAPIEN-3 Periprosthetic Leakage Evaluation Versus Medtronic CoreValve in Transfemoral Aortic Valve Implantation
A study testing Transcatheter aortic valve replacement, Medtronic CoreValve system and Edwards SAPIEN bioprosthesis in people with Periprosthetic Aortic Valve Regurgitation After TAVI, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Aortic Valve Regurgitation After TAVI
- What is being tested?
- Transcatheter aortic valve replacement, Medtronic CoreValve system and Edwards SAPIEN bioprosthesis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2013to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients unable or unwilling to give informed consent.
- Patients who are excluded from this study because of the size of their aortic annulus diameter.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Transcatheter aortic valve replacement, Medtronic CoreValve system, Edwards SAPIEN bioprosthesis
- Keywords
- Periprosthetic aortic valve regurgitation, 3D transesophageal echocardiography, Cardiac MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve replacementProcedure or surgery
Transcatheter aortic valve replacement
Medtronic CoreValve systemDevice
Transcatheter aortic valve replacement with the Medtronic CoreValve system
Edwards SAPIEN bioprosthesisDevice
Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis
| Study group | Role | What they receive |
|---|---|---|
| Edwards SAPIEN bioprosthesis | Active comparator | Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis Receives: Procedure: Transcatheter aortic valve replacement; Device: Edwards SAPIEN bioprosthesis |
| Medtronic CoreValve® system | Active comparator | Transcatheter aortic valve replacement with the Medtronic CoreValve system Receives: Procedure: Transcatheter aortic valve replacement; Device: Medtronic CoreValve system |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with 3DTEE
PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with 3DTEE
Measured: Within 5 days after TAVR
Secondary outcomes (5)
PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with cardiac magnetic resonance imaging
PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with cardiac magnetic resonance imaging
Measured: Within 5 days after TAVR
PAR (expressed as regurgitant volume [ml]) 6 months after TAVR, as diagnosed with 3DTEE
PAR (expressed as regurgitant volume [ml]) 6 months after TAVR, as diagnosed with 3DTEE
Measured: At 6 months +/- 2 weeks after TAVR
Clinical endpoints according to the VARC-2
Clinical endpoints according to the VARC-2
Measured: 30 days, 6months, 1 year
Quality of life, presented as scores of the short form 36 item health status survey (SF-36)
Quality of life, presented as scores of the short form 36 item health status survey (SF-36)
Measured: 1 year
Quality of life, according to the Euroqol questionnaire (EQ-5D)
Quality of life, presented as scores of the Euroqol questionnaire (EQ-5D)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2016
- Study completionMay 2017
Why it stopped: slow enrollment, study device unavailable ( CoreValve)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periprosthetic Aortic Valve Regurgitation After TAVIStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pieter Stella, UMC Utrecht
- Investigators
- Pieter Stella, MD, PhD, Principal investigator, UMC UtrechtPierfrancesco Agostoni, MD, PhD, Study chair, UMC UtrechtNynke Kooistra, MD, Study director, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982032
- Sponsor's protocol ID
- NL43116.041.13
- Acronym
- ELECT
- Status last verified
- Nov 2018
- First submitted
- 27 Aug 2013
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kooistra NHM, Abawi M, Voskuil M, Urgel K, Samim M, Nijhoff F, Nathoe HM, Doevendans PAFM, Chamuleau SAJ, Leenders GEH, Leiner T, Abrahams AC, van der Worp HB, Agostoni P, Stella PR. Randomised comparison of a balloon-expandable and self-expandable valve with quantitative assessment of aortic regurgitation using magnetic resonance imaging. Neth Heart J. 2020 May;28(5):253-265. doi: 10.1007/s12471-020-01414-0.
PubMed 32246266
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edwards SAPIEN-3 Periprosthetic Leakage Evaluation Versus Medtronic CoreValve in Transfemoral Aortic Valve Implantation (ELECT) Trial
- ClinicalTrials.gov ID
- NCT01982032
- Acronym / sponsor ID
- ELECT / NL43116.041.13
- Keywords
- Periprosthetic aortic valve regurgitation, 3D transesophageal echocardiography, Cardiac MRI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment, study device unavailable ( CoreValve)
- Enrolment
- 56 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Edwards SAPIEN bioprosthesis | Active comparator | Procedure: Transcatheter aortic valve replacement, Device: Edwards SAPIEN bioprosthesisTranscatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis |
| Medtronic CoreValve® system | Active comparator | Procedure: Transcatheter aortic valve replacement, Device: Medtronic CoreValve systemTranscatheter aortic valve replacement with the Medtronic CoreValve system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients unable or unwilling to give informed consent.
- Patients who are excluded from this study because of the size of their aortic annulus diameter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter aortic valve replacementTranscatheter aortic valve replacement | Procedure or surgery | Edwards SAPIEN bioprosthesis, Medtronic CoreValve® system |
| Medtronic CoreValve systemTranscatheter aortic valve replacement with the Medtronic CoreValve system | Device | Medtronic CoreValve® system |
| Edwards SAPIEN bioprosthesisTranscatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis | Device | Edwards SAPIEN bioprosthesis |
Primary outcome
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
5 secondary outcomes
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]) 6 months after TAVR, as diagnosed with 3DTEE
Time frame: At 6 months +/- 2 weeks after TAVR
Clinical endpoints according to the VARC-2
Time frame: 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, according to the Euroqol questionnaire (EQ-5D)
Time frame: 1 year
Results and safety
The study was stopped early (reason given: slow enrollment, study device unavailable ( CoreValve)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Derived from this study: PubMed 32246266Kooistra NHM, Abawi M, Voskuil M, Urgel K, Samim M, Nijhoff F, Nathoe HM, Doevendans PAFM, Chamuleau SAJ, Leenders GEH, Leiner T, Abrahams AC, van der Worp HB, Agostoni P, Stella PR. Randomised comparison of a balloon-expandable and self-expandable valve with quantitative assessment of aortic regurgitation using magnetic resonance imaging. Neth Heart J. 2020 May;28(5):253-265. doi: 10.1007/s12471-020-01414-0.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pieter Stella, MD, PhD principal investigator
UMC Utrecht
Pierfrancesco Agostoni, MD, PhD study chair
UMC Utrecht
Nynke Kooistra, MD study director
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter aortic valve replacement, Medtronic CoreValve system and Edwards SAPIEN bioprosthesis in people with Periprosthetic Aortic Valve Regurgitation After TAVI, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow enrollment, study device unavailable ( CoreValve)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with 3DTEE (time frame: Within 5 days after TAVR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01982032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.