Clinical trial NCT01982032: Edwards SAPIEN-3 Periprosthetic Leakage Evaluation Versus Medtronic CoreValve in Transfemoral Aortic Valve Implantation
Official title: Edwards SAPIEN-3 Periprosthetic Leakage Evaluation Versus Medtronic CoreValve in Transfemoral Aortic Valve Implantation (ELECT) Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Periprosthetic Aortic Valve Regurgitation After TAVI
Keywords: Periprosthetic aortic valve regurgitation
3D transesophageal echocardiography
Cardiac MRI
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with 3DTEE
timeFrame: Within 5 days after TAVR
Secondary outcomes:
measure: PAR (expressed as regurgitant volume [ml]) after TAVR, as diagnosed with cardiac magnetic resonance imaging
timeFrame: Within 5 days after TAVR
measure: PAR (expressed as regurgitant volume [ml]) 6 months after TAVR, as diagnosed with 3DTEE
timeFrame: At 6 months +/- 2 weeks after TAVR
measure: Clinical endpoints according to the VARC-2
timeFrame: 30 days, 6months, 1 year
measure: Quality of life, presented as scores of the short form 36 item health status survey (SF-36)
timeFrame: 1 year
measure: Quality of life, according to the Euroqol questionnaire (EQ-5D)
timeFrame: 1 year
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Pieter Stella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: Pierfrancesco Agostoni, MD, PhD
role: STUDY_CHAIR
affiliation: UMC Utrecht
name: Nynke Kooistra, MD
role: STUDY_DIRECTOR
References:
citation: 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.