Phase
Condition
Congestive Heart Failure
Heart Valve Disease
Cardiac Disease
Treatment
Abbott Mechanical Heart Valve (MHV) Regent™
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient is eligible to be implanted with Regent to replace a native or prostheticaortic valve per Regent's IFU.
Subject will be >18 years of age at time of being consented.
Subject, provides written informed consent prior to any clinicalinvestigation-specific procedure.
Exclusion
Exclusion Criteria:
Subject is unable to tolerate anticoagulation therapy.
Subject has active endocarditis.
Subject is currently participating in another clinical investigation which mayinterfere with the effectiveness of anticoagulation therapy.
Pregnant or nursing subjects and those who plan pregnancy during the clinicalinvestigation follow-up period. Women of child-bearing potential must have adocumented negative pregnancy test within one week prior to enrollment.
Subject has anomalous anatomy or medical, surgical, psychological or social historyor conditions that, in the investigator's opinion, could limit the subject's abilityto participate in the clinical investigation or to comply with follow-uprequirements of the clinical investigation results.
Subject is unable to read or write or has a mental illness or disability thatimpairs their ability to provide written informed consent.
Subject's life expectancy is less than 1 year in the opinion of the Investigator.
Study Design
Study Description
Connect with a study center
The People's Hospital of Gaozhou
Gaozhou,
ChinaSite Not Available
The People's Hospital of Gaozhou
Gaozhou 1810295,
ChinaSite Not Available
The Second Affiliated Hospital of Nanchang University
Nanchang,
ChinaSite Not Available
The Second Affiliated Hospital of Nanchang University
Nanchang 1800163,
ChinaSite Not Available
Ningbo Medical Center Lihuili Hospital
Ningbo,
ChinaSite Not Available
Ningbo Medical Center Lihuili Hospital
Ningbo 1799397,
ChinaSite Not Available
Wuhan Union Hospital of China
Wuhan,
ChinaSite Not Available
Wuhan Union Hospital of China
Wuhan 1791247,
ChinaSite Not Available
Fuwai Central China Cardiovascular Hospital
Zhengzhou,
ChinaSite Not Available
Affiliated Hospital of Zunyi Medical University
Zunyi,
ChinaSite Not Available
Affiliated Hospital of Zunyi Medical University
Zunyi 1783621,
ChinaSite Not Available

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