NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience

Not yet recruiting

• Conditions: Bicuspid Aortic Valve

• Registration Number: NCT06375590
• Lead Sponsor: Didier TCHETCHE

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-07
• Study First Submitted QC: 2024-04-16
• Last Update Submitted: 2024-04-16
• Study First Posted: 2024-04-19
• Last Update Posted: 2024-04-19
• Study Start: 2024-05-01
• Primary Completion: 2025-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Age ≥ 18 years.
2. NYHA ≥ 2 and/or syncope and/or angina.
3. Symptomatic severe calcified aortic stenosis with AVA < 1 cm2 AND peak velocity > 4 m/s or mean gradient > 40 mmHg or DVI < 0.25'.
4. Patient judged by the Heart Team as indicated for TAVI.
5. Anatomical suitability for transfemoral-TAVI with Navitor, based on MSCT assessment.
6. 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 Navitor.
8. Unsuitable peripheral vasculature for transfemoral Navitor.
9. Type 2 bicuspid aortic valve
10. Excessive leaflet calcifications
11. Moderate or severe raphe calcifications
12. Severe LVOT calcifications
13. Perimeter-derived annular dimension exceeding IFU recommendation
14. Dilated ascending aorta >45 mm

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
30-day device success (Rate)	30-day	as indicated in the VARC-3 criteria

Secondary Outcome Measures

Name	Time	Method
1 year at least moderate bioprosthetic valve deterioration	1-year	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
30 days and 1 year all-cause and cardiovascular mortality	1-year
30 days and 1 year stroke	1-year
1 year severe patient-prosthesis mismatch	1-year	defined as EOAi \< 0.65 cm2/m2

Trial Locations

Locations (1)

Clinique Pasteur; 🇫🇷 Toulouse, Occitanie, France