Bicuspid Aortic ValveNCT06375590
NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience
An observational study of Bicuspid Aortic Valve, run by Didier TCHETCHE at 1 site in France.
Trial summary
The aim of this prospective registry is to evaluate the clinical impact of the new Navitor prosthesis (Abbott, Minneapolis, MN, USA) in BAV and evaluate both the main sizing methods (the classical annular or the supra-annular with ICD measurement at 4 mm above the virtual basal ring). 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
- 1 May 2024to 1 May 2026
- 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.
- Symptomatic severe calcified aortic stenosis with AVA < 1 cm2 AND peak velocity > 4 m/s or mean gradient > 40 mmHg or DVI < 0.25'.
- Patient judged by the Heart Team as indicated for TAVI.
- Anatomical suitability for transfemoral-TAVI with Navitor, 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.
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- Unsuitable aortic root anatomy for Navitor.
- Unsuitable peripheral vasculature for transfemoral Navitor.
- Type 2 bicuspid aortic valve
- Excessive leaflet calcifications
- Moderate or severe raphe calcifications
- Severe LVOT calcifications
- Perimeter-derived annular dimension exceeding IFU recommendation
- Dilated ascending aorta >45 mm
Trial locations and contacts
1 site in 1 country.
France1 site
Clinique Pasteur
Toulouse, Occitanie, 31076
Didier Tchétché, MD
Didier Tchétché
About this study
The aim of this prospective registry is to evaluate the clinical impact of the new Navitor prosthesis (Abbott, Minneapolis, MN, USA) in BAV and evaluate both the main sizing methods (the classical annular or the supra-annular with ICD measurement at 4 mm above the virtual basal ring).
- Conditions
- Bicuspid Aortic Valve
- Being tested
- Transcatheter Aortic Valve Implantation
- Keywords
- Bicuspid aortic valve, TAVI, Navitor
- 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 stenosis with the Navitor platform
| Study group | Role | What they receive |
|---|---|---|
| Bicuspid aortic valve | Treated with Navitor platform Receives: Device: Transcatheter Aortic Valve Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day device success (Rate)
as indicated in the VARC-3 criteria
Measured: 30-day
Secondary outcomes (4)
1 year at least moderate bioprosthetic valve deterioration
defined as increase in mean transvalvular gradient ≥10 mmHg resulting in mean gradient ≥20 mmHg with concomitant decrease in EOA ≥0.3 cm2 or ≥25% and/or decrease in Doppler velocity index ≥0.1 or ≥20% compared with echocardiographic assessment performed 1-3 months post-procedure, OR new occurrence or increase of ≥1 grade of intra-prosthetic AR resulting in ≥ moderate AR
Measured: 1-year
1 year severe patient-prosthesis mismatch
defined as EOAi < 0.65 cm2/m2
Measured: 1-year
30 days and 1 year all-cause and cardiovascular mortality
Measured: 1-year
30 days and 1 year stroke
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Didier TCHETCHE
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor-investigator, Didier TCHETCHE, Clinique Pasteur
- Investigators
- Didier Tchétché, MD, Principal investigator, Clinique Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375590
- Sponsor's protocol ID
- 2024-NavIIcusp
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Mutual anonymized database. Substudies anticipated.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience
- ClinicalTrials.gov ID
- NCT06375590
- Acronym / sponsor ID
- 2024-NavIIcusp
- Conditions
- Bicuspid Aortic Valve
- Keywords
- Bicuspid aortic valve, TAVI, Navitor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Didier TCHETCHEUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 19 Apr 2024 (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.
The aim of this prospective registry is to evaluate the clinical impact of the new Navitor prosthesis (Abbott, Minneapolis, MN, USA) in BAV and evaluate both the main sizing methods (the classical annular or the supra-annular with ICD measurement at 4 mm above the virtual basal ring).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bicuspid aortic valve | – | Device: Transcatheter Aortic Valve ImplantationTreated with Navitor platform |
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 (6 listed)
- Age ≥ 18 years.
- NYHA ≥ 2 and/or syncope and/or angina.
- Symptomatic severe calcified aortic stenosis with AVA < 1 cm2 AND peak velocity > 4 m/s or mean gradient > 40 mmHg or DVI < 0.25'.
- Patient judged by the Heart Team as indicated for TAVI.
- Anatomical suitability for transfemoral-TAVI with Navitor, based on MSCT assessment.
Key exclusion criteria (14 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 stenosis with the Navitor platform | Device | Bicuspid aortic valve |
Primary outcome
30-day device success (Rate)
Time frame: 30-day
as indicated in the VARC-3 criteria
4 secondary outcomes
1 year at least moderate bioprosthetic valve deterioration
Time frame: 1-year
1 year severe patient-prosthesis mismatch
Time frame: 1-year
30 days and 1 year all-cause and cardiovascular mortality
Time frame: 1-year
30 days and 1 year stroke
Time frame: 1-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: Undecided. Mutual anonymized 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.
Didier Tchétché, MD principal investigator
Clinique Pasteur
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 Didier TCHETCHE 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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Didier Tchétché, MD (+33562211699, d.tchetche@clinique-pasteur.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day device success (Rate) (time frame: 30-day). 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 19 Apr 2024.