NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience

NCT06375590 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2024-NavIIcusp
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Bicuspid Aortic Valve

Keywords

Bicuspid aortic valve; TAVI; Navitor

Outcome Measures

Primary Outcomes (1)

• 30-day device success (Rate)

  as indicated in the VARC-3 criteria

  30-day

Secondary Outcomes (4)

• 1 year at least moderate bioprosthetic valve deterioration

  1-year

• 1 year severe patient-prosthesis mismatch

  1-year

• 30 days and 1 year all-cause and cardiovascular mortality

  1-year

• 30 days and 1 year stroke

  1-year

Study Arms (1)

Bicuspid aortic valve

Treated with Navitor platform

Device: Transcatheter Aortic Valve Implantation

Interventions

Transcatheter Aortic Valve Implantation DEVICE

Transcatheter treatment of bicuspid stenosis with the Navitor platform

Also known as: Transcatheter Aortic Valve Replacement

Bicuspid aortic valve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Type 2 bicuspid aortic valve
• Excessive leaflet calcifications
• Moderate or severe raphe calcifications
• Severe LVOT calcifications
• Perimeter-derived annular dimension exceeding IFU recommendation
• Dilated ascending aorta \>45 mm

Sponsors & Collaborators

• Didier TCHETCHE: lead
• Abbott: collaborator

Study Sites (1)

Clinique Pasteur

Toulouse, Occitanie, 31076, France

Location

MeSH Terms

Conditions

Bicuspid Aortic Valve Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Aortic Valve Disease; Heart Valve Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Didier Tchétché, MD

  Clinique Pasteur

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Didier Tchétché, MD

CONTACT

+33562211699; d.tchetche@clinique-pasteur.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of structural heart disease program

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 19, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

FR (1)