Edwards SAPIEN Periprosthetic Leakage Evaluation Versus Medtronic CoreValve in Transfemoral Aortic Valve Implantation (the ELECT Trial)
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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 |
- PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with 3DTEE [ Time Frame: Within 5 days after TAVR ] [ Designated as safety issue: No ]
- 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 2017 |
| Estimated Primary Completion Date: | May 2016 (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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01982032
| Contact: Masieh Abawi | 0031887559497 | m.abawi@umcutrecht.nl |
| Netherlands | |
| University Medical Center Utrecht | Recruiting |
| Utrecht, Netherlands, 3584 CX | |
| Contact: Masieh Abawi 0031887559497 m.abawi@umcutrecht.nl | |
| Contact: Pierfrancesco Agostoni, MD, Phd 0031887556167 p.agostoni@umcutrecht.nl | |
| Principal Investigator: | Pierfrancesco Agostoni, MD, PhD | UMC Utrecht | |
| Study Chair: | Pieter Stella, MD, PhD | UMC Utrecht | |
| Study Director: | Masieh Abawi | UMC Utrecht |
More Information
No publications provided
| Responsible Party: | Masieh Abawi, 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: | February 22, 2015 |
| 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 Cardiovascular Diseases Heart Diseases Heart Valve Diseases |
ClinicalTrials.gov processed this record on March 03, 2015