Balloon-Expandable Versus Self-expanding Transcatheter Heart Valve for Treatment of Symptomatic Native Aortic Valve Stenosis

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
CHU de Besançon
RECRUITING
Besançon
CHU de Caen
RECRUITING
Caen
Hôpital Privé Saint-Martin
RECRUITING
Caen
CHU de Clermont-Ferrand
RECRUITING
Clermont-ferrand
AP-HP Hôpitaux Universitaires Henri Mondor
RECRUITING
Créteil
CHU de Grenoble
RECRUITING
Grenoble
AP-HM Hôpital la Timone
NOT_YET_RECRUITING
Marseille
Institut Cardiovasculaire Paris Sud
RECRUITING
Massy
CHU de Montpellier
RECRUITING
Montpellier
CHU de Nîmes
RECRUITING
Nîmes
AP-HP Hôpitaux Universitaires Pitié Salpêtrière
RECRUITING
Paris
Institut Mutualiste Montsouris
RECRUITING
Paris
CHU de Bordeaux Hôpital Pellegrin
RECRUITING
Pessac
CHU Reims - Hôpitam Robert Debré
RECRUITING
Reims
CHU de Saint-Etienne
RECRUITING
Saint-etienne
CHU de Nantes - Hôpital Laennec
RECRUITING
Saint-herblain
Centre Médico Chirurgical Arnault Tzanck
RECRUITING
Saint-laurent-du-var
CHU de Strasbourg
RECRUITING
Strasbourg
CHU de Toulouse
RECRUITING
Toulouse
CHU de Tours
RECRUITING
Tours
Médipôle Lyon Villeurbanne
NOT_YET_RECRUITING
Villeurbanne
Contact Information
Primary
Eric Van Belle, MD,PhD
ericvanbelle@aol.com
0320115962
Time Frame
Start Date: 2023-04-19
Estimated Completion Date: 2025-07-19
Participants
Target number of participants: 1862
Treatments
Experimental: TAVI with balloon-expandable valve (Sapien 3/Ultra, Edwards Lifesciences©)
Active_comparator: TAVI with self-expanding valve (Evolut R/Pro, Medtronic©)
Sponsors
Collaborators: Ministry of Health, France
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov