BEST: Balloon-expandable vs Self-Expanding Transcatheter Heart Valve

Sponsor

University Hospital, Lille (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05454150

Collaborator

Ministry of Health, France (Other)

1,862

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis	Device: balloon-expandable valve Device: self-expanding valve	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1862 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAVI with balloon-expandable valve (Sapien 3/Ultra, Edwards Lifesciences©)	Device: balloon-expandable valve Sapien 3/Ultra, Edwards Lifesciences©
Active Comparator: TAVI with self-expanding valve (Evolut R/Pro, Medtronic©)	Device: self-expanding valve Evolut R/Pro, Medtronic©

Arm

Intervention/Treatment

Experimental: TAVI with balloon-expandable valve (Sapien 3/Ultra, Edwards Lifesciences©)

Device: balloon-expandable valve

Sapien 3/Ultra, Edwards Lifesciences©

Active Comparator: TAVI with self-expanding valve (Evolut R/Pro, Medtronic©)

Device: self-expanding valve

Evolut R/Pro, Medtronic©

Outcome Measures

Primary Outcome Measures

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

Rate of Technical success [At exit from procedure room]
Rate of Device Success [At 90 days]
Rate of Early safety [At 90 days]
All-cause mortality at 1 year [At 1 year after procedure]
All-stroke or TIA at 1 year [At 1 year after procedure]
All hospitalization for heart failure [After post implant period, at 90 days, at 1 year after procedure]
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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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