Regent China Post-Market Clinical Follow-up Study

NCT05330468 | Completed Results

• 1 other identifier: ABT-CIP-10412
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint: The Freedom From Valve-related Mortality

  Valve-related mortality is any death caused by structural valve deterioration, nonstructural dysfunction, valve thrombosis, embolism, bleeding event, or operated valve endocarditis; death related to reintervention on the operated valve; or sudden, unexplained death. Deaths caused by heart failure in patients with advanced myocardial disease and satisfactorily functioning cardiac valves are not counted. Specific causes of valve-related deaths should be reported.

  At one year

• Primary Performance Endpoint: The Freedom From Valve-related Reoperation

  Valve-related reoperation includes any reintervention that is a surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces the previously implanted prosthesis or repaired valve.

  At one year

Study Arms (1)

Abbott Regent MHV

Subjects implanted with an Abbott Regent MHV replacement of the aortic valve.

Device: Abbott Mechanical Heart Valve (MHV) Regent™

Interventions

Abbott Mechanical Heart Valve (MHV) Regent™ DEVICE

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

Abbott Regent MHV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This clinical investigation will enroll male and female subjects who will be undergoing replacement of a native or prosthetic aortic heart valve. Patients must meet all general eligibility criteria and provide written informed consent prior to sites conducting any investigation-specific procedures not considered standard of care.

You may qualify if:

• Patient is eligible to be implanted with Regent to replace a native or prosthetic aortic valve per Regent's IFU.
• Subject will be \>18 years of age at time of being consented.
• Subject, provides written informed consent prior to any clinical investigation-specific procedure.

You may not qualify if:

• Subject is unable to tolerate anticoagulation therapy.
• Subject has active endocarditis.
• Subject is currently participating in another clinical investigation which may interfere with the effectiveness of anticoagulation therapy.
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. Women of child-bearing potential must have a documented negative pregnancy test within one week prior to enrollment.
• Subject has anomalous anatomy or medical, surgical, psychological or social history or conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
• Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent.
• Subject's life expectancy is less than 1 year in the opinion of the Investigator.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (5)

The People's Hospital of Gaozhou

Gaozhou, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Location

Ningbo Medical Center Lihuili Hospital

Ningbo, China

Location

Wuhan Union Hospital of China

Wuhan, China

Location

Affiliated Hospital of Zunyi Medical University

Zunyi, China

Location

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Director, Clinical Programs Structural Interventions & Cardiac Surgery
• Organization: Abbott

ryan.palmer@abbott.com

(651)-202-8362

Study Officials

• Kyle Brunner

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 15, 2022
• Study Start: March 29, 2022
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: October 27, 2025
• Results First Posted: October 27, 2025

Record last verified: 2025-09

Locations

CN (5)