Balloon-Expandable Versus Self-expanding Transcatheter Heart Valve for Treatment of Symptomatic Native Aortic Valve Stenosis (BEST)
- Conditions
- Aortic Valve Stenosis
- Interventions
- Device: self-expanding valveDevice: balloon-expandable valve
- Registration Number
- NCT05454150
- Lead Sponsor
- University Hospital, Lille
- 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 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1862
- 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)
- Severe aortic regurgitation (>3+)
- Refusal to participate to FRANCE-TAVI registry
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAVI with self-expanding valve (Evolut R/Pro, Medtronic©) self-expanding valve - TAVI with balloon-expandable valve (Sapien 3/Ultra, Edwards Lifesciences©) balloon-expandable valve -
- Primary Outcome Measures
Name Time Method All-cause mortality at 90-day after TAVI An independent clinical event committee (CEC) will adjudicate clinical events according to the VARC-3 definitions.
- Secondary Outcome Measures
Name Time Method All-cause mortality at 1 year At 1 year after procedure An independent clinical event committee (CEC) will adjudicate clinical events according to the VARC-3 definitions.
All hospitalization for procedure- or valve-related causes After post implant period, at 90 days, at 1 year after procedure Baseline clinical and echocardiographic parameters At Basline, after post implant period, at 90 days, at 1 year after procedure An independant corelaboratory will review all images and
Rate of Device Success At 90 days An independent clinical event committee (CEC) will adjudicate clinical events according to the VARC-3 definitions.
All-stroke or TIA at 1 year At 1 year after procedure Rate of Technical success At exit from procedure room An independent clinical event committee (CEC) will adjudicate clinical events according to the VARC-3 definitions.
Baseline anatomical aortic valve CT-scan parameters including Valve morphology: bicuspid vs. tricuspid aortic valve At Basline, after post implant period, at 90 days, at 1 year after procedure An independant corelaboratory will review all images
Rate of Early safety At 90 days An independent clinical event committee (CEC) will adjudicate clinical events according to the VARC-3 definitions.
All hospitalization for heart failure After post implant period, at 90 days, at 1 year after procedure An independent clinical event committee (CEC) will adjudicate clinical events according to the VARC-3 definitions.
Trial Locations
- Locations (21)
Hôpital Privé Saint-Martin
🇫🇷Caen, France
CHU de Besançon
🇫🇷Besançon, France
CHU de Caen
🇫🇷Caen, France
AP-HM Hôpital la Timone
🇫🇷Marseille, France
Institut Cardiovasculaire Paris Sud
🇫🇷Massy, France
AP-HP Hôpitaux Universitaires Pitié Salpêtrière
🇫🇷Paris, France
CHU de Nîmes
🇫🇷Nîmes, France
CHU Reims - Hôpitam Robert Debré
🇫🇷Reims, France
CHU de Nantes - Hôpital Laennec
🇫🇷Saint-Herblain, France
Institut Mutualiste Montsouris
🇫🇷Paris, France
Centre Médico Chirurgical Arnault Tzanck
🇫🇷Saint-Laurent-du-Var, France
CHU de Bordeaux Hôpital Pellegrin
🇫🇷Pessac, France
CHU de Strasbourg
🇫🇷Strasbourg, France
CHU de Tours
🇫🇷Tours, France
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
AP-HP Hôpitaux Universitaires Henri Mondor
🇫🇷Créteil, France
CHU de Grenoble
🇫🇷Grenoble, France
CHU de Montpellier
🇫🇷Montpellier, France
CHU de Saint-Etienne
🇫🇷Saint-Étienne, France
CHU de Toulouse
🇫🇷Toulouse, France
Médipôle Lyon Villeurbanne
🇫🇷Villeurbanne, France