Clinical trial NCT05330468: Regent China Post-Market Clinical Follow-up Study
Official title: Regent China Post-Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Valvular Heart Disease
Aortic Valve Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2022-04-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from valve-related mortality
timeFrame: Assessed at 5 years
measure: Freedom from valve-related reoperation.
timeFrame: Assessed at 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gaozhou
country: China
facility: The People's Hospital of Gaozhou
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
city: Wuhan
country: China
facility: Wuhan Union Hospital of China
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
Study officials:
affiliation: Abbott
name: Kyle Brunner
role: STUDY_DIRECTOR
References: