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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05330468
Other study ID # ABT-CIP-10412
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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