Regent China Post-Market Clinical Follow-up Study

Abbott

Status: Completed

Conditions: Valvular Heart Disease; Aortic Valve Disease

Treatments: Device: Abbott Mechanical Heart Valve (MHV) Regent™

Study type: Observational

Funder types: Industry

Identifiers

NCT05330468

ABT-CIP-10412

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

200 participants in 1 patient group

Abbott Regent MHV

Description:

Subjects implanted with an Abbott Regent MHV replacement of the aortic valve.

Treatment:

Device: Abbott Mechanical Heart Valve (MHV) Regent™