Bicuspid Aortic ValveBIVOLUTXNCT03495050
BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.
An observational study of Bicuspid Aortic Valve, run by Clinique Pasteur at 1 site in France.
Trial summary
Prospective non interventional, observational registry of 150 patients undergoing TAVI with Evolut platform for bicuspid aortic stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bicuspid Aortic Valve
- What is being tested?
- Transcatheter Aortic Valve Implantation
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2018to 17 Dec 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease
Who may be able to join
- Age ≥18 years.
- NYHA≥2 and/or syncope and/or angina.
- Patient judged by the Heart Team as indicated for TAVI.
- Anatomical suitability for transfemoral-TAVI with Evolut Pro or Evolut R XL, based on MSCT assessment.
- Estimated life-expectancy>1 year.
Who cannot join
- Age <18 years
- Asymptomatic patients
- Estimated life expectancy<1 year
- Pure aortic regurgitation.
- LVEF<20%
- No baseline MSCT evaluation.
- Unsuitable aortic root anatomy for Evolut Pro or XL.
- Unsuitable peripheral vasculature for transfemoral Evolut Pro or XL.
Trial locations and contacts
1 site in 1 country.
About this study
Prospective non interventional, observational registry of 150 patients undergoing TAVI with Evolut platform for bicuspid aortic stenosis.
Read the detailed description
Study Design Study Design: prospective non-interventional multicenter registry Screening: MSCT submitted to core lab \& sizing strategy pre-declared (annular sizing, supra-annular sizing, mix of both methods) Follow up: MSCT and TTE to cooper lab
TAVI treatment Predilatation according to aortic annulus Dmin Evolut Pro (23-26-29) and Evolut R 34 XL Annular anchoring of the THV Postdilatation according to the operators' discretion Study Population All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease
Inclusion Criteria 1. Age ≥18 years. 2. NYHA≥2 and/or syncope and/or angina. 3. Patient judged by the Heart Team as indicated for TAVI. 4. Anatomical suitability for transfemoral-TAVI with Evolut Pro or Evolut R XL, based on MSCT assessment.
- Estimated life-expectancy>1 year.
Exclusion Criteria 1. Age <18 years 2. Asymptomatic patients 3. Estimated life expectancy<1 year 4. Pure aortic regurgitation. 5. LVEF<20% 6. No baseline MSCT evaluation. 7. Unsuitable aortic root anatomy for Evolut Pro or XL. 8. Unsuitable peripheral vasculature for transfemoral Evolut Pro or XL. Primary Endpoint Valve performane Secondary endpoints 30 day and 1 year mortality Patient-prosthesis mismatch Ellipticity index at 30 days Follow-up 30 days: physical examination, ECG, TTE /MSCT upon operators' judgement
1 year: physical examination, ECG, TTE.
- Conditions
- Bicuspid Aortic Valve
- Being tested
- Transcatheter Aortic Valve Implantation
- Keywords
- Bicuspid, TAVI, TAVR, self-expanding, Evolut
- Medical subject headings
- Bicuspid Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve ImplantationDevice
Also called Transcatheter Aortic Valve Replacement
Transcatheter treatment of bicuspid aortic stenosis with the Evolut Pro/XL platform
What is being measured
The primary outcome is the main question the study is designed to answer.
Valve performance
effective orifice area<0.85 cm2/m2 and/or mean gradient>20 mmHg and/or aortic regurgitation>moderate
Measured: 30 days
Valve performance
effective orifice area<0.85 cm2/m2 and/or mean gradient>20 mmHg and/or aortic regurgitation>moderate
Measured: one year
Secondary outcomes (3)
mortality
Measured: 30 days and one year
Patient-prosthesis mismatch
indexed effective area <0.65 cm2/m2
Measured: 30 days and 1 year
Ellipticity index at 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start5 Jun 2018
- Primary completion10 Feb 2020
- Study completion17 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bicuspid Aortic ValveStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Clinique Pasteur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495050
- Sponsor's protocol ID
- 2018-A00290-55
- Acronym
- BIVOLUTX
- Status last verified
- Jun 2026
- First submitted
- 3 Mar 2018
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Mutual ananymized database. Substudies anticipated.
Publications
Tchetche D, Ziviello F, De Biase C, De Backer O, Hovasse T, Leroux L, Petronio AS, Saint-Etienne C, Teles RC, Modine T, Sudre A, Teiger E, Mylotte D, Souteyrand G, Piazza N, Casassus F, Sondergaard L, Angelillis M, Nolasco T, Siddiqui S, Kardys I, Dumonteil N, Van Mieghem NM. Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis: the international, multicentre, prospective BIVOLUTX registry. EuroIntervention. 2023 Aug 21;19(6):502-511. doi: 10.4244/EIJ-D-23-00021.
PubMed 37203860Tchetche D, de Biase C, van Gils L, Parma R, Ochala A, Lefevre T, Hovasse T, De Backer O, Sondergaard L, Bleiziffer S, Lange R, Kornowski R, Landes U, Norgaard BL, Biasco L, Philippart R, Molina-Martin de Nicolas J, Mylotte D, Lemee C, Dumonteil N, Van Mieghem NM. Bicuspid Aortic Valve Anatomy and Relationship With Devices: The BAVARD Multicenter Registry. Circ Cardiovasc Interv. 2019 Jan;12(1):e007107. doi: 10.1161/CIRCINTERVENTIONS.118.007107.
PubMed 30626202
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.
- ClinicalTrials.gov ID
- NCT03495050
- Acronym / sponsor ID
- BIVOLUTX / 2018-A00290-55
- Conditions
- Bicuspid Aortic Valve
- Keywords
- Bicuspid, TAVI, TAVR, self-expanding, Evolut
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Clinique PasteurUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 17 Dec 2020 (actual)
- First posted
- 11 Apr 2018 (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.
Prospective non interventional, observational registry of 150 patients undergoing TAVI with Evolut platform for bicuspid aortic stenosis.
Detailed description
Study Design Study Design: prospective non-interventional multicenter registry Screening: MSCT submitted to core lab \& sizing strategy pre-declared (annular sizing, supra-annular sizing, mix of both methods) Follow up: MSCT and TTE to cooper lab
TAVI treatment Predilatation according to aortic annulus Dmin Evolut Pro (23-26-29) and Evolut R 34 XL Annular anchoring of the THV Postdilatation according to the operators' discretion Study Population All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease
Inclusion Criteria 1. Age ≥18 years. 2. NYHA≥2 and/or syncope and/or angina. 3. Patient judged by the Heart Team as indicated for TAVI. 4. Anatomical suitability for transfemoral-TAVI with Evolut Pro or Evolut R XL, based on MSCT assessment.
- Estimated life-expectancy>1 year.
Exclusion Criteria 1. Age <18 years 2. Asymptomatic patients 3. Estimated life expectancy<1 year 4. Pure aortic regurgitation. 5. LVEF<20% 6. No baseline MSCT evaluation. 7. Unsuitable aortic root anatomy for Evolut Pro or XL. 8. Unsuitable peripheral vasculature for transfemoral Evolut Pro or XL. Primary Endpoint Valve performane Secondary endpoints 30 day and 1 year mortality Patient-prosthesis mismatch Ellipticity index at 30 days Follow-up 30 days: physical examination, ECG, TTE /MSCT upon operators' judgement
1 year: physical examination, ECG, TTE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease
Key inclusion criteria (5 listed)
- Age ≥18 years.
- NYHA≥2 and/or syncope and/or angina.
- Patient judged by the Heart Team as indicated for TAVI.
- Anatomical suitability for transfemoral-TAVI with Evolut Pro or Evolut R XL, based on MSCT assessment.
- Estimated life-expectancy>1 year.
Key exclusion criteria (8 listed)
- Age <18 years
- Asymptomatic patients
- Estimated life expectancy<1 year
- Pure aortic regurgitation.
- LVEF<20%
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 |
|---|---|---|
| Transcatheter Aortic Valve ImplantationAlso: Transcatheter Aortic Valve ReplacementTranscatheter treatment of bicuspid aortic stenosis with the Evolut Pro/XL platform | Device | – |
Primary outcome
Valve performance
Time frame: 30 days
effective orifice area<0.85 cm2/m2 and/or mean gradient>20 mmHg and/or aortic regurgitation>moderate
Valve performance
Time frame: one year
effective orifice area<0.85 cm2/m2 and/or mean gradient>20 mmHg and/or aortic regurgitation>moderate
3 secondary outcomes
mortality
Time frame: 30 days and one year
Patient-prosthesis mismatch
Time frame: 30 days and 1 year
Ellipticity index at 30 days
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Results publication: PubMed 37203860Tchetche D, Ziviello F, De Biase C, De Backer O, Hovasse T, Leroux L, Petronio AS, Saint-Etienne C, Teles RC, Modine T, Sudre A, Teiger E, Mylotte D, Souteyrand G, Piazza N, Casassus F, Sondergaard L, Angelillis M, Nolasco T, Siddiqui S, Kardys I, Dumonteil N, Van Mieghem NM. Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis: the international, multicentre, prospective BIVOLUTX registry. EuroIntervention. 2023 Aug 21;19(6):502-511. doi: 10.4244/EIJ-D-23-00021.
- Derived from this study: PubMed 30626202Tchetche D, de Biase C, van Gils L, Parma R, Ochala A, Lefevre T, Hovasse T, De Backer O, Sondergaard L, Bleiziffer S, Lange R, Kornowski R, Landes U, Norgaard BL, Biasco L, Philippart R, Molina-Martin de Nicolas J, Mylotte D, Lemee C, Dumonteil N, Van Mieghem NM. Bicuspid Aortic Valve Anatomy and Relationship With Devices: The BAVARD Multicenter Registry. Circ Cardiovasc Interv. 2019 Jan;12(1):e007107. doi: 10.1161/CIRCINTERVENTIONS.118.007107.
- Individual participant dataSharing planned: Undecided. Mutual ananymized database. Substudies anticipated.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bicuspid Aortic Valve, run by Clinique Pasteur at 1 site 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Valve performance (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03495050, which also lists 2 linked publications.
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 18 Jun 2026.