Balloon-Expandable Versus Self-expanding Transcatheter Heart Valve for Treatment of Symptomatic Native Aortic Valve Stenosis (BEST)
BEST
2 other identifiers
interventional
1,960
1 country
21
Brief Summary
Over the last years, several randomized studies comparing transcatheter aortic valve implantation (TAVI) to surgical aortic valve replacement (SAVR) have established TAVI as a treatment option in symptomatic patients with aortic stenosis (AS) (1,2,3). Most transcatheter heart valves (THV) available are designed on either a balloon-expandable (BE) or a self-expanding (SE) concept. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2022
CompletedFirst Posted
Study publicly available on registry
July 12, 2022
CompletedStudy Start
First participant enrolled
April 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2035
ExpectedDecember 4, 2025
November 1, 2025
2.5 years
July 7, 2022
November 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
composite of: device technical failure at exit from procedure room and/or all-cause mortality and/or disabling stroke
An independent clinical event committee (CEC) will adjudicate clinical events according to the VARC-3 definitions.
at 90-day after TAVI
Secondary Outcomes (11)
Composite of device failure, and/or all-cause mortality and/or disabling stroke
at 1 year after TAVI
2Composite of device technical failure, all-cause mortality and/or disabling stroke
At 90 days after TAVI
Device technical failure
at exit from procedure room
Safety
at 90 days after TAVI
Device Success
at 90 days after TAVI
- +6 more secondary outcomes
Other Outcomes (2)
1) Rate of patients included in BEST Study successfully matched with the SNDS via the probabilistic linking algorithm of the FRANCE-TAVI registry.
at 1 year after TAVI
1) The rate of Hypoattenuated Leaflet Thrombosis (HALT) of any severity as assessed by CT-Scan and transthoracic echocardiography
at 1 year after TAVI
Study Arms (2)
TAVI with balloon-expandable valve (Sapien 3/Ultra, Edwards Lifesciences©)
EXPERIMENTALTAVI with self-expanding valve (Evolut R/Pro, Medtronic©)
ACTIVE COMPARATORInterventions
Sapien 3/Ultra, Edwards Lifesciences©
Evolut R/Pro, Medtronic©
Eligibility Criteria
You may not qualify if:
- Symptomatic severe aortic stenosis defined according to the current echocardiography criteria of the European Society of Cardiology guidelines2.
- 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)
- Age \< 18 years old
- 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)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Van Belle, MD,PhD
University Hospital, Lille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2022
First Posted
July 12, 2022
Study Start
April 19, 2023
Primary Completion
October 29, 2025
Study Completion (Estimated)
December 29, 2035
Last Updated
December 4, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share