NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience

Didier TCHETCHE

Status: Not yet enrolling

Conditions: Bicuspid Aortic Valve

Treatments: Device: Transcatheter Aortic Valve Implantation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06375590

2024-NavIIcusp

Details and patient eligibility

About

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).

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Bicuspid aortic valve

Description:

Treated with Navitor platform

Treatment:

Device: Transcatheter Aortic Valve Implantation