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Regent China Post-Market Clinical Follow-up Study | Clinical Trials | Clareo Health

COMPLETED

Regent China Post-Market Clinical Follow-up Study

NCT05330468•Abbott Medical Devices

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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

Key Dates

Start Date

March 29, 2022

Primary Completion Date

October 10, 2024

Completion Date

October 10, 2024

Last Updated

October 27, 2025

Enrollment

200

ACTUAL participants

Conditions

Valvular Heart DiseaseAortic Valve Disease

Interventions

Abbott Mechanical Heart Valve (MHV) Regent™

DEVICE

SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation

NCT07366671

TAVI(Transcatheter Aortic Valve Implantation)Aortic Valve Disease

View study

RECRUITINGPHASE2/PHASE3

Sildinafil in Pulmonary Hypertension-Rheumatic Chronic Valvular Disease(RCT)

NCT07462260

Pulmonary HypertensionRheumatic Valvular Heart Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Regent China Post-Market Clinical Follow-up Study

Inclusion Criteria

Exclusion Criteria

SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation

Sildinafil in Pulmonary Hypertension-Rheumatic Chronic Valvular Disease(RCT)

Prospective Evaluation of AI-ECG for SHD Detection

PPG to Predict Ejection Fraction and Other Echographic Data in the General Population

J-Valve Transfemoral Pivotal Study

Prospective Long-Term Outcomes of a Standardized Ross Procedure