An observational study in Bicuspid Aortic Valve, sponsored by Didier TCHETCHE. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-19.
Sponsored by Didier TCHETCHE · Observational
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).
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's planned enrollment of 150 is below the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →This is the only study on the registry with Didier TCHETCHE as lead sponsor.
Counted across the registry records on this site, refreshed daily.
All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease
Exclusion Criteria:
Treated with Navitor platform
Device: Transcatheter Aortic Valve Implantation
Transcatheter treatment of bicuspid stenosis with the Navitor platform
Also known as: Transcatheter Aortic Valve Replacement
30-day device success (Rate)
as indicated in the VARC-3 criteria
Time frame: 30-day
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
Time frame: 1-year
1 year severe patient-prosthesis mismatch
defined as EOAi \< 0.65 cm2/m2
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
Plan to share: Undecided — Mutual anonymized database. Substudies anticipated.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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