Clinical trial NCT05454150: Balloon-Expandable Versus Self-expanding Transcatheter Heart Valve for Treatment of Symptomatic Native Aortic Valve Stenosis (BEST)
Official title: Balloon-Expandable Versus Self-expanding Transcatheter Heart Valve for Treatment of Symptomatic Native Aortic Valve Stenosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Aortic valve stenosis
TAVI
Balloon-expandable transcatheter heart valve
Self-expanding transcatheter heart valve,
heart valve disease
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2022-07-12
Enrollment: 1862
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: 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


Eligibility criteria: The study population will be comprised of all patients with severe, calcific, symptomatic aortic stenosis eligible to percutaneous transfemoral TAVI with BE or SE-valve according to the investigating center heart team.

The inclusion/exclusion criteria are limited and primarily intend to select patient eligible to both BE and SE-valve. This allows for a study cohort whose composition is expected to be close to an all-comers cohort and therefore representative for the standard TAVI population seen in daily practice.

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: All-cause mortality
timeFrame: at 90-day after TAVI
Secondary outcomes:
measure: Rate of Technical success
timeFrame: At exit from procedure room
measure: Rate of Device Success
timeFrame: At 90 days
measure: Rate of Early safety
timeFrame: At 90 days
measure: All-cause mortality at 1 year
timeFrame: At 1 year after procedure
measure: All-stroke or TIA at 1 year
timeFrame: At 1 year after procedure
measure: All hospitalization for heart failure
timeFrame: After post implant period, at 90 days, at 1 year after procedure
measure: All hospitalization for procedure- or valve-related causes
timeFrame: After post implant period, at 90 days, at 1 year after procedure
measure: Baseline clinical and echocardiographic parameters
timeFrame: At Basline, after post implant period, at 90 days, at 1 year after procedure
measure: Baseline anatomical aortic valve CT-scan parameters including Valve morphology: bicuspid vs. tricuspid aortic valve
timeFrame: At Basline, after post implant period, at 90 days, at 1 year after procedure
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Caen
country: France
facility: CHU de Caen
city: Caen
country: France
facility: Hôpital Privé Saint-Martin
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Créteil
country: France
facility: AP-HP Hôpitaux Universitaires Henri Mondor
city: Grenoble
country: France
facility: CHU de Grenoble
city: Marseille
country: France
facility: AP-HM Hôpital la Timone
city: Massy
country: France
facility: Institut Cardiovasculaire Paris Sud
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nîmes
country: France
facility: CHU de Nîmes
city: Paris
country: France
facility: AP-HP Hôpitaux Universitaires Pitié Salpêtrière
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Pessac
country: France
facility: CHU de Bordeaux Hôpital Pellegrin
city: Reims
country: France
facility: CHU Reims - Hôpitam Robert Debré
city: Saint-Herblain
country: France
facility: CHU de Nantes - Hôpital Laennec
city: Saint-Laurent-du-Var
country: France
facility: Centre Médico Chirurgical Arnault Tzanck
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tours
country: France
facility: CHU de Tours
city: Villeurbanne
country: France
facility: Médipôle Lyon Villeurbanne
Study officials:
affiliation: University Hospital, Lille
name: Eric Van Belle, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: