Balloon-Expandable Versus Self-expanding Transcatheter Heart Valve for Treatment of Symptomatic Native Aortic Valve Stenosis (BEST)
NCT ID: NCT05454150
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1960 participants
INTERVENTIONAL
2023-04-19
2035-12-29
Brief Summary
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Despite major differences, both designs are recommended to be used indifferently in most of the clinical situations and a significant number of centers only implant one of this two THV design. It remains unclear however, whether these 2 very different THV concepts are achieving similar or different clinical outcomes and could be considered a single "Class" of device. While there is an urgent clinical need to clarify this issue in an exponentially growing therapeutic field, to date no large randomized study powered to compare the 2 THV designs on individual endpoints has been conducted or initiated. Recently, two large-scale French registry-based propensity matched analyses, including more than 30,000 patients, have reported a higher 90 days and 1-year mortality with the use of SE as compared to BE-valve (4,5). However, as the propensity-score matching-approach cannot rule out residual confounders, and as some of the most recent THV iterations were not part of the investigation, there is an urgent need to conduct a randomized trial sufficiently powered to compare head-to-head the latest generation of SE and BE-valve on all-cause mortality. In addition, two small randomized studies have recently showed the inferiority of a new SE-valve compared to BE-valve and SE-THV (SCOPE1 trial, J Lanz. Lancet. 2019 Nov 2;394(10209):1619-1628. and SCOPE 2 trial, Circulation in press), thus further questioning wether THV should be considered as a single \"Class\" regardless the THV design.
The objective of the present randomized clinical investigation will be to evaluate the impact of THV design (SE vs BE) on the risk of all-cause mortality at 90 days and 1 year.
The present clinical investigation will the first randomized clinical investigation to compare head to head the benefit of BE-valve over SE-valve on total mortality and /or disabling stroke at 90 days and 1-year using a superiority design. Previous head-to-head studies included only a small number of patients, non-inferiority designs and combined endpoints. This clinical investigation will be the first to generate sufficient evidences to change clinical practice and international guidelines to clarify whether one THV design is superior (or not) to the other one (BE vs SE-valve). The result of the clinical investigation is key for clinicians indicating the treatment and for the patients receiving the treatment
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TAVI with balloon-expandable valve (Sapien 3/Ultra, Edwards Lifesciences©)
balloon-expandable valve
Sapien 3/Ultra, Edwards Lifesciences©
TAVI with self-expanding valve (Evolut R/Pro, Medtronic©)
self-expanding valve
Evolut R/Pro, Medtronic©
Interventions
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balloon-expandable valve
Sapien 3/Ultra, Edwards Lifesciences©
self-expanding valve
Evolut R/Pro, Medtronic©
Eligibility Criteria
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Inclusion Criteria
* Heart team of the investigating center agrees that the patient is eligible to TAVI with BE-valve SAPIEN 3 (Edwards Lifesciences©) (or further iterations of the same family) OR TAVI with the SE-valve Evolut-R/pro (Medtronic©) (or futher iterations of the same family).
* Heart team of the investigating center agrees that TAVI is feasible via percutaneous transfemoral approach.
* Written informed consent to the BEST study
* Written informed consent to the FRANCE-TAVI registy
* All valve anatomy are authorized (bicuspid or tricuspid aortic valve)
Exclusion Criteria
* Patient with legal protection
* Non-affiliation to a social security scheme
* Pregnancy
* Subject participating in another research protocol on TAVI procedure
* Patients presenting with an anatomy that is regarded unsuitable for the implantation of one of the two valve types
* TAVI through nontransfemoral approach or surgical cutdown
* Valve-in-valve procedure (TAVI in TAVI or TAVI in surgical aortic bioprosthesis)
* Implantation of Accurate Neo or Accurate Neo2 valve (Boston scientific)
* Severe aortic regurgitation (\>3+)
* Refusal to participate to FRANCE-TAVI registry
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
OTHER
University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Eric Van Belle, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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CH Annecy Genevois
Annecy, , France
CHU de Besançon
Besançon, , France
CHU de Caen
Caen, , France
Hôpital Privé Saint-Martin
Caen, , France
CHU de Clermont-Ferrand
Clermont-Ferrand, , France
AP-HP Hôpitaux Universitaires Henri Mondor
Créteil, , France
CHU de Grenoble
Grenoble, , France
Institut Cardiovasculaire Paris Sud
Massy, , France
CHU de Montpellier
Montpellier, , France
CHU de Nîmes
Nîmes, , France
AP-HP Hôpitaux Universitaires Pitié Salpêtrière
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
CHU de Bordeaux Hôpital Pellegrin
Pessac, , France
CHU Reims - Hôpitam Robert Debré
Reims, , France
CHU de Saint-Etienne
Saint-Etienne, , France
CHU de Nantes - Hôpital Laennec
Saint-Herblain, , France
Centre Médico Chirurgical Arnault Tzanck
Saint-Laurent-du-Var, , France
CHU de Strasbourg
Strasbourg, , France
CHU de Toulouse
Toulouse, , France
CHU de Tours
Tours, , France
Médipôle Lyon Villeurbanne
Villeurbanne, , France
Countries
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Other Identifiers
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2021_0513
Identifier Type: -
Identifier Source: org_study_id
2021-A02554-37
Identifier Type: OTHER
Identifier Source: secondary_id
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