Regent China Post-Market Clinical Follow-up Study

NCT05330468 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-10-27

Study results available
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Summary

Regent China Post-Market Clinical Follow-Up (RC-PMCF): this clinical study is to confirm the safety and performance of Abbott's Regent MHV for replacement of native or prosthetic aortic valves in a Chinese population.

Conditions

  • Valvular Heart Disease
  • Aortic Valve Disease

Interventions

DEVICE

Abbott Mechanical Heart Valve (MHV) Regent™

SJM Regent™- Standard cuff (Model number AGN-751); SJM Regent™- FlexCuff™ (Model number AGFN-756)

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Kyle Brunner · Abbott

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-29
Primary Completion
2024-10-10
Completion
2024-10-10

Countries

  • China

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 NCT05330468 on ClinicalTrials.gov