NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Bicuspid Aortic Valve
• Intervention / Treatment: Device: Transcatheter Aortic Valve Implantation

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Didier Tchétché, MD; Phone Number: +33562211699; Email: d.tchetche@clinique-pasteur.com

Study Locations

• France
  • Occitanie
    • Toulouse, Occitanie, France, 31076
      • Clinique Pasteur
      • Principal Investigator: Didier Tchetche
      • Contact: Didier Tchétché, MD
      • Sub-Investigator: Chiara De Biase, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bicuspid aortic valve; Treated with Navitor platform	Device: Transcatheter Aortic Valve Implantation; Transcatheter treatment of bicuspid stenosis with the Navitor platform; Other Names: Transcatheter Aortic Valve Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day device success (Rate)	as indicated in the VARC-3 criteria	30-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
1 year severe patient-prosthesis mismatch	defined as EOAi < 0.65 cm2/m2	1-year
30 days and 1 year all-cause and cardiovascular mortality		1-year
30 days and 1 year stroke		1-year

Collaborators and Investigators

• Sponsor: Didier TCHETCHE
• Collaborators: Abbott
• Investigators: Principal Investigator: Didier Tchétché, MD, Clinique Pasteur

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 7, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Bicuspid aortic valve; TAVI; Navitor
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Aortic Valve Disease; Ventricular Outflow Obstruction; Heart Defects, Congenital; Cardiovascular Abnormalities; Aortic Valve Stenosis; Heart Valve Diseases; Bicuspid Aortic Valve Disease
• Other Study ID Numbers: 2024-NavIIcusp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Mutual anonymized database. Substudies anticipated.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No