Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05454150

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Annecy Genevois, Annecy, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

balloon-expandable valve

Device

Sapien 3/Ultra, Edwards Lifesciences©

self-expanding valve

Device

Evolut R/Pro, Medtronic©

Primary outcomes

  1. composite of: device technical failure at exit from procedure room and/or all-cause mortality and/or disabling stroke

    Time frame: at 90-day after TAVI

    An independent clinical event committee (CEC) will adjudicate clinical events according to the VARC-3 definitions.

Secondary outcomes

  1. Composite of device failure, and/or all-cause mortality and/or disabling stroke

    Time frame: at 1 year after TAVI

    An independent clinical event committee (CEC) will adjudicate clinical events according to the VARC-3 definitions.

  2. 2Composite of device technical failure, all-cause mortality and/or disabling stroke

    Time frame: At 90 days after TAVI

    An independent clinical event committee (CEC) will adjudicate clinical events according to the VARC-3 definitions.

  3. Device technical failure

    Time frame: at exit from procedure room

    Freedom from mortality, Successful access, delivery of the device and retrieval of the delivery system, Correct positioning of a single prosthetic heart valve into the proper anatomical location, Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication

  4. Safety

    Time frame: at 90 days after TAVI

    • Technical success at exit from procedure room (VARC 3)*
    • Freedom from all-cause mortality
    • Freedom from all stroke
    • Freedom from VARC type 2-4 bleeding
    • Freedom from major vascular access-related complication
    • Freedom from cardiac structural complication
    • Freedom from acute kidney injury stage 3 or 4
    • Freedom from moderate or severe aortic regurgitation
    • Freedom from new permanent pacemaker due to procedure-related conduction abnormalities
    • Freedom from surgery or intervention related to the device

  5. Device Success

    Time frame: at 90 days after TAVI

    • Technical success at exit from procedure room
    • Freedom from mortality
    • Freedom form surgery or intervention related to the device or to a major vascular or access-related or major cardiac structural complication
    • Intended performance of the valve (mean gradient < 20mmHg, peak velocity <3m/s, Doppler Velocity index ≥ 0.25, and less than moderate aortic regurgitation

  6. Clinical efficacy Clinical efficacy

    Time frame: at 1 year after TAVI

    Ao Technical success at exit from procedure room (VARC 3)*

    • Freedom from all-cause mortality
    • Freedom from all stroke
    • Freedom from hospitalization for procedure- or valve-related causes
    • Freedom from KCCQ Overall Summary Score <45 or decline from baseline of >10 point (i.e. Unfavourable Outcome)

  7. Valve-related clinical efficacy

    Time frame: at 1 year after TAVI

    • Technical success of the TAVI procedure*
    • Intended performance of the valve
    • Freedom from severe PPM at discharge (or 90 days)†
    • Freedom from endocarditis†
    • Freedom from bioprosthesis Valve Failure (BVF)
    • Freedom from stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies)
    • Freedom from VARC Type 2-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents, used specifically for valve-related concerns

  8. composite outcome from a patient perspective

    Time frame: AT 90 days and 1 year afet TAVU

    The rate of favourable outcome risk of death

  9. Valve Durability defined as all-cause BVF tricuspid aortic valve

    Time frame: At 90days and 1 year after TAVI

    An independant corelaboratory will review all images. An independent clinical event committee (CEC) will adjudicate clinical events according to the VARC-3 definitions.

  10. 11) Stage 2 or 3 hemodynamic valve deterioration

    Time frame: At 1 year after TAVI

    according to VARC-3 n independent clinical event committee (CEC) adjudicate clinical events

  11. device technical failure at exit from procedure room and/or all-cause mortality and/or disabling strok

    Time frame: at 3, 5, 7 and 10 years after TAVI

    according to VARC-3 n independent clinical event committee (CEC) adjudicate clinical events

Other outcomes

  1. 1) Rate of patients included in BEST Study successfully matched with the SNDS via the probabilistic linking algorithm of the FRANCE-TAVI registry.

    Time frame: at 1 year after TAVI

    o A successful matching will be defined as >98% of patients of the BEST study successfully matched with SNDS

  2. 1) The rate of Hypoattenuated Leaflet Thrombosis (HALT) of any severity as assessed by CT-Scan and transthoracic echocardiography

    Time frame: at 1 year after TAVI

    An independant corelaboratory will review all images

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
  • Ministry of Health, France

Registry information

Official study title

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

Acronym: BEST

Important dates

Study start
2023
Primary completion
2025
Study completion
2035
First posted
Jul 12, 2022
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.