Regent China Post-Market Clinical Follow-up Study

Aortic Valve Disease Clinical Trial

Official title:

Regent China Post-Market Clinical Follow-up Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05330468
• Other study ID #: ABT-CIP-10412
• Status: Active, not recruiting
• Start date: March 29, 2022
• Est. completion date: August 31, 2028

Study information

• Verified date: May 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: August 31, 2028
• Est. primary completion date: March 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Disease
• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Device:
• Abbott Mechanical Heart Valve (MHV) Regent™
SJM Regent™- Standard cuff (Model number AGN-751); SJM Regent™- FlexCuff™ (Model number AGFN-756)

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from valve-related mortality	Freedom from valve-related mortality	Assessed at 5 years
Primary	Freedom from valve-related reoperation.	Freedom from valve-related reoperation.	Assessed at 5 years