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NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience

France150 participantsStarted 2024-05-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. Age \< 18 years
✕. Asymptomatic patients
✕. Estimated life expectancy \< 1 year
✕. Pure aortic regurgitation.
✕. LVEF \< 20%
✕. No baseline MSCT evaluation.
✕. Unsuitable aortic root anatomy for Navitor.
✕. Unsuitable peripheral vasculature for transfemoral Navitor.

What they're measuring

30-day device success (Rate)

Timeframe: 30-day

Trial details

NCT IDNCT06375590

SponsorDidier TCHETCHE

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-05-01

Contact for this trial

Didier Tchétché, MD

+33562211699 d.tchetche@clinique-pasteur.com

View on ClinicalTrials.gov More Bicuspid Aortic Valve trials