NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience

Bicuspid Aortic Valve Clinical Trial

Official title:

NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06375590
• Other study ID #: 2024-NavIIcusp
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: May 1, 2026

Study information

• Verified date: April 2024
• Source: Clinique Pasteur
• Contact: Didier Tchétché, MD
• Phone: +33562211699
• Email: d.tchetche[@]clinique-pasteur.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Bicuspid Aortic Valve
• Bicuspid Aortic Valve Disease
• Heart Valve Diseases

Intervention

Device:
• Transcatheter Aortic Valve Implantation
Transcatheter treatment of bicuspid stenosis with the Navitor platform

Locations

Country	Name	City	State
France	Clinique Pasteur	Toulouse	Occitanie

Sponsors (2)

Lead Sponsor	Collaborator
Didier TCHETCHE	Abbott

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day device success (Rate)	as indicated in the VARC-3 criteria	30-day
Secondary	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	1-year
Secondary	1 year severe patient-prosthesis mismatch	defined as EOAi < 0.65 cm2/m2	1-year
Secondary	30 days and 1 year all-cause and cardiovascular mortality		1-year
Secondary	30 days and 1 year stroke		1-year