Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)

NCT05082454 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 108

Last updated 2025-02-05

No results posted yet for this study

Summary

The ASCEND post-market clinical follow-up study is undertaken to evaluate safety and clinical performance of the On-X Ascending Aortic Prosthesis (AAP) used in surgical aortic valve replacement.

Conditions

  • Aortic Valve Disease

Interventions

DEVICE

Open repair

Open repair of the aortic heart valve and ascending thoracic aorta

Sponsors & Collaborators

  • JOTEC GmbH

    lead INDUSTRY

Principal Investigators

  • Davide Pacini, Prof. Dr. · Policlinico S. Orsola-Malpighi

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-20
Primary Completion
2024-02-06
Completion
2029-03-31
FDA Device
Yes

Countries

  • United States
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

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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 NCT05082454 on ClinicalTrials.gov