About this trial
The purpose of this study is to evaluate the safety and effectiveness of transcatheter aortic valve replacement in Chinese population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with symptomatic aortic stenosis/regurgitation
Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
Patients are technical and anatomical eligible for interventions
Disqualifiers
A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: Aspirin Heparin (HIT/HITTS) and bivalirudin Nitinol (titanium or nickel) Ticlopidine and clopidogrel Contrast media
Subject refuses a blood transfusion.
Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
Life expectancy is less than one year
Trial design
Single group
Treatments tested in this trial
transcatheter aortic valve replacement
Procedure/Surgery
Treatment groups
Trial outcomes
Primary outcomes
Death from any cause
Secondary outcomes
stroke
death from cardiac causes
myocardial infarction
repeated hospitalization
Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.