Regent China Post-Market Clinical Follow-up Study

Terminated

• Conditions: Valvular Heart Disease; Aortic Valve Disease

• Registration Number: NCT05330468
• Lead Sponsor: Abbott Medical Devices

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.

Detailed 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.

Study Timeline

• Study Start: 2022-03-29
• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-15
• Primary Completion: 2024-10-10
• Study Completion: 2024-10-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patient is eligible to be implanted with Regent to replace a native or prosthetic aortic 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 clinical investigation-specific procedure.

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 may interfere with the effectiveness of anticoagulation therapy.
4. 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.
5. 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.
6. Subject is unable to read or write or has a mental illness or disability that impairs 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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from valve-related mortality	Assessed at 5 years	Freedom from valve-related mortality
Freedom from valve-related reoperation.	Assessed at 5 years	Freedom from valve-related reoperation.

Trial Locations

Locations (5)

The People's Hospital of Gaozhou; 🇨🇳 Gaozhou, China

The Second Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, China

Ningbo Medical Center Lihuili Hospital; 🇨🇳 Ningbo, China

Wuhan Union Hospital of China; 🇨🇳 Wuhan, China

Affiliated Hospital of Zunyi Medical University; 🇨🇳 Zunyi, China