Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of transcatheter aortic valve replacement in Chinese population.

Detailed Description
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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.

Official Title
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THE TORCH TRIAL：Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population

Conditions
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Symptomatic Aortic Stenosis

Intervention / Treatment
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* Procedure: transcatheter aortic valve replacement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aortic Stenosis/regurgitation<br>Transcatheter aortic valve replacement | Procedure: transcatheter aortic valve replacement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death from any cause |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stroke |  | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years | 
| 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 | 
| device success | 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) | 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 | 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. | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years | 
| transcatheter valve failure | leaflet thrombosis formation, reduced leaflet motion or leaflet thickening of the prosthetic valve | 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years | 
| 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 |