MedTrace Logo

Post-Market Clinical Follow Up Study With Navitor Valve

NCT06008080 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-06-06

No results posted yet for this study

Summary

Evaluation of the safety and performance of the Navitor TAVI System in a Global Study

Conditions

  • Aortic Stenosis

Interventions

DEVICE

Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System

Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Alper Öner, MD · Universitätsmedizin Rostock, Germany

  • Nicolas Dumonteil, MD · Clinique Pasteur Toulouse, France

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-29
Primary Completion
2026-09-30
Completion
2031-12-31
FDA Device
Yes

Countries

  • Australia
  • France
  • Germany
  • Italy
  • Netherlands
  • Portugal
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06008080 on ClinicalTrials.gov