Aortic Valve StenosisBESTNCT05454150
Balloon-Expandable Versus Self-expanding Transcatheter Heart Valve for Treatment of Symptomatic Native Aortic Valve Stenosis (BEST)
A study testing balloon-expandable valve and self-expanding valve in people with Aortic Valve Stenosis, run by University Hospital, Lille at 21 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- balloon-expandable valve and self-expanding valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,960 participants
- Where
- 21 sitesFrance
- Study dates
- 19 Apr 2023to 29 Dec 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
CH Annecy Genevois
Annecy
CHU de Besançon
Besançon
CHU de Caen
Caen
Hôpital Privé Saint-Martin
Caen
CHU de Clermont-Ferrand
Clermont-Ferrand
AP-HP Hôpitaux Universitaires Henri Mondor
Créteil
CHU de Grenoble
Grenoble
Institut Cardiovasculaire Paris Sud
Massy
CHU de Montpellier
Montpellier
CHU de Nîmes
Nîmes
AP-HP Hôpitaux Universitaires Pitié Salpêtrière
Paris
Institut Mutualiste Montsouris
Paris
CHU de Bordeaux Hôpital Pellegrin
Pessac
CHU Reims - Hôpitam Robert Debré
Reims
CHU de Saint-Etienne
Saint-Etienne
CHU de Nantes - Hôpital Laennec
Saint-Herblain
Centre Médico Chirurgical Arnault Tzanck
Saint-Laurent-du-Var
CHU de Strasbourg
Strasbourg
CHU de Toulouse
Toulouse
CHU de Tours
Tours
Médipôle Lyon Villeurbanne
Villeurbanne
About this study
Official title: Balloon-Expandable Versus Self-expanding Transcatheter Heart Valve for Treatment of Symptomatic Native Aortic Valve Stenosis
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.
Read more
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
- Conditions
- Aortic Valve Stenosis
- Being tested
- balloon-expandable valve, self-expanding valve
- Keywords
- Aortic valve stenosis, TAVI, Balloon-expandable transcatheter heart valve, Self-expanding transcatheter heart valve,, heart valve disease
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon-expandable valveDevice
Sapien 3/Ultra, Edwards Lifesciences©
self-expanding valveDevice
Evolut R/Pro, Medtronic©
| Study group | Role | What they receive |
|---|---|---|
| TAVI with balloon-expandable valve (Sapien 3/Ultra, Edwards Lifesciences©) | Experimental | Not described Receives: Device: balloon-expandable valve |
| TAVI with self-expanding valve (Evolut R/Pro, Medtronic©) | Active comparator | Not described Receives: Device: self-expanding valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite of: device technical failure at exit from procedure room and/or all-cause mortality and/or disabling stroke
An independent clinical event committee (CEC) will adjudicate clinical events according to the VARC-3 definitions.
Measured: at 90-day after TAVI
Secondary outcomes (11)
Composite of device failure, and/or all-cause mortality and/or disabling stroke
An independent clinical event committee (CEC) will adjudicate clinical events according to the VARC-3 definitions.
Measured: at 1 year after TAVI
2Composite of device technical failure, all-cause mortality and/or disabling stroke
An independent clinical event committee (CEC) will adjudicate clinical events according to the VARC-3 definitions.
Measured: At 90 days after TAVI
Device technical failure
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
Measured: at exit from procedure room
Safety
- 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
Measured: at 90 days after TAVI
Device Success
- 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
Measured: at 90 days after TAVI
Clinical efficacy Clinical efficacy
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)
Measured: at 1 year after TAVI
Valve-related clinical efficacy
- 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
Measured: at 1 year after TAVI
composite outcome from a patient perspective
The rate of favourable outcome risk of death
Measured: AT 90 days and 1 year afet TAVU
Valve Durability defined as all-cause BVF tricuspid aortic valve
An independant corelaboratory will review all images. An independent clinical event committee (CEC) will adjudicate clinical events according to the VARC-3 definitions.
Measured: At 90days and 1 year after TAVI
11) Stage 2 or 3 hemodynamic valve deterioration
according to VARC-3 n independent clinical event committee (CEC) adjudicate clinical events
Measured: At 1 year after TAVI
device technical failure at exit from procedure room and/or all-cause mortality and/or disabling strok
according to VARC-3 n independent clinical event committee (CEC) adjudicate clinical events
Measured: at 3, 5, 7 and 10 years after TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start19 Apr 2023
- Primary completion29 Oct 2025
- Study completion29 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,960 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Responsible party
- Sponsor
- Investigators
- Eric Van Belle, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454150
- Sponsor's protocol ID
- 2021_0513
- Other IDs
- 2021-A02554-37
- Acronym
- BEST
- Status last verified
- Nov 2025
- First submitted
- 7 Jul 2022
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon-Expandable Versus Self-expanding Transcatheter Heart Valve for Treatment of Symptomatic Native Aortic Valve Stenosis
- ClinicalTrials.gov ID
- NCT05454150
- Acronym / sponsor ID
- BEST / 2021_0513
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic valve stenosis, TAVI, Balloon-expandable transcatheter heart valve, Self-expanding transcatheter heart valve,, heart valve disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,960 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 29 Oct 2025 (actual)
- Study completion
- 29 Dec 2035 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVI with balloon-expandable valve (Sapien 3/Ultra, Edwards Lifesciences©) | Experimental | Device: balloon-expandable valve |
| TAVI with self-expanding valve (Evolut R/Pro, Medtronic©) | Active comparator | Device: self-expanding valve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| balloon-expandable valveSapien 3/Ultra, Edwards Lifesciences© | Device | TAVI with balloon-expandable valve (Sapien 3/Ultra, Edwards Lifesciences©) |
| self-expanding valveEvolut R/Pro, Medtronic© | Device | TAVI with self-expanding valve (Evolut R/Pro, Medtronic©) |
Primary outcome
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.
11 secondary outcomes
Composite of device failure, and/or all-cause mortality and/or disabling stroke
Time frame: at 1 year after TAVI
2Composite of device technical failure, all-cause mortality and/or disabling stroke
Time frame: At 90 days after TAVI
Device technical failure
Time frame: at exit from procedure room
Safety
Time frame: at 90 days after TAVI
Device Success
Time frame: at 90 days after TAVI
Clinical efficacy Clinical efficacy
Time frame: at 1 year after TAVI
Valve-related clinical efficacy
Time frame: at 1 year after TAVI
composite outcome from a patient perspective
Time frame: AT 90 days and 1 year afet TAVU
Valve Durability defined as all-cause BVF tricuspid aortic valve
Time frame: At 90days and 1 year after TAVI
11) Stage 2 or 3 hemodynamic valve deterioration
Time frame: At 1 year after TAVI
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Van Belle, MD,PhD principal investigator
University Hospital, Lille
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balloon-expandable valve and self-expanding valve in people with Aortic Valve Stenosis, run by University Hospital, Lille at 21 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.