Regent China Post-Market Clinical Follow-up Study

Last updated: September 30, 2025
Sponsor: Abbott Medical Devices
Overall Status: Completed

Phase

N/A

Condition

Congestive Heart Failure

Heart Valve Disease

Cardiac Disease

Treatment

Abbott Mechanical Heart Valve (MHV) Regent™

Clinical Study ID

NCT05330468
ABT-CIP-10412
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient is eligible to be implanted with Regent to replace a native or prostheticaortic valve per Regent's IFU.

  2. Subject will be >18 years of age at time of being consented.

  3. Subject, provides written informed consent prior to any clinicalinvestigation-specific procedure.

Exclusion

Exclusion Criteria:

  1. Subject is unable to tolerate anticoagulation therapy.

  2. Subject has active endocarditis.

  3. Subject is currently participating in another clinical investigation which mayinterfere with the effectiveness of anticoagulation therapy.

  4. Pregnant or nursing subjects and those who plan pregnancy during the clinicalinvestigation follow-up period. Women of child-bearing potential must have adocumented negative pregnancy test within one week prior to enrollment.

  5. Subject has anomalous anatomy or medical, surgical, psychological or social historyor conditions that, in the investigator's opinion, could limit the subject's abilityto participate in the clinical investigation or to comply with follow-uprequirements of the clinical investigation results.

  6. Subject is unable to read or write or has a mental illness or disability thatimpairs their ability to provide written informed consent.

  7. Subject's life expectancy is less than 1 year in the opinion of the Investigator.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Abbott Mechanical Heart Valve (MHV) Regent™
Phase:
Study Start date:
March 29, 2022
Estimated Completion Date:
October 10, 2024

Study Description

The purpose of the RC-PMCF study is to meet the post-market clinical followup (PMCF) requirements of the National Medical Products Administration (NMPA). The primary objective of 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. This is a prospective, observational, multi-center study of subjects clinically indicated for implantation of an Abbott Medical's Regent Valve.

Connect with a study center

  • The People's Hospital of Gaozhou

    Gaozhou,
    China

    Site Not Available

  • The People's Hospital of Gaozhou

    Gaozhou 1810295,
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang,
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang 1800163,
    China

    Site Not Available

  • Ningbo Medical Center Lihuili Hospital

    Ningbo,
    China

    Site Not Available

  • Ningbo Medical Center Lihuili Hospital

    Ningbo 1799397,
    China

    Site Not Available

  • Wuhan Union Hospital of China

    Wuhan,
    China

    Site Not Available

  • Wuhan Union Hospital of China

    Wuhan 1791247,
    China

    Site Not Available

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou,
    China

    Site Not Available

  • Affiliated Hospital of Zunyi Medical University

    Zunyi,
    China

    Site Not Available

  • Affiliated Hospital of Zunyi Medical University

    Zunyi 1783621,
    China

    Site Not Available

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