Symptomatic Aortic Stenosis
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of transcatheter aortic valve replacement in Chinese population.
Detailed description
Subjects enrolled are those who undergo physical exams and screening tests and were classified as a patient with symptomatic aortic stenosis or severe aortic regurgitation. They are then performed transcatheter aortic valve replacement.
Interventions
PROCEDUREtranscatheter aortic valve replacement
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death from any cause | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| death from cardiac causes | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years | — |
| myocardial infarction | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years | — |
| repeated hospitalization | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years， 10 years | — |
| acute kidney injury | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years | — |
| vascular complications | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years,10 years | — |
| bleeding events | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years | — |
| stroke | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years | — |
| Functional Improvement from baseline per New York Heart Association functional classification | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years | — |
| permanent pacemaker implantation | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years | number of patients who develop permanent third-degree or type 2(Mobitz) Secondary atrioventricular block after transcatheter aortic valve replacement and need permanent pacemaker implantation. |
| transcatheter valve failure | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years | leaflet thrombosis formation, reduced leaflet motion or leaflet thickening of the prosthetic valve |
| changes in ascending aorta diameter | 1 year,2 years, 3 years, 4 years, 5 years，10 years | — |
| Death from all causes | 30 days, 6 months,1 year,2 years, 3 years, 4 years, 5 years，10 years | — |
| device success | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years | Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient \<20 mmHg or peak velocity \< 3 m/s, and no moderate or severe paravalvular regurgitation) |
Countries
China
Contacts
Primary ContactXianbao Liu, MD
Backup ContactJian-an Wang, MD,PhD
Outcome results
None listed