NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience

April 16, 2024 updated by: Didier TCHETCHE
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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Didier TCHETCHE

Collaborators

Abbott

Investigators

  • Principal Investigator: Didier Tchétché, MD, Clinique Pasteur

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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