Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population
- Conditions
- Symptomatic Aortic Stenosis
- Interventions
- Procedure: transcatheter aortic valve replacement
- Registration Number
- NCT02803294
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Aortic Stenosis/regurgitation transcatheter aortic valve replacement Transcatheter aortic valve replacement
- Primary Outcome Measures
Name Time Method Death from any cause 1 year
- Secondary Outcome Measures
Name Time Method bleeding events 30days, 6months,1 year,2 years, 3 years, 4 years, 5 years，10 years 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
stroke 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 vascular complications 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 death from cardiac causes 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 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)
myocardial infarction 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 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.
Trial Locations
- Locations (1)
The Second Affiliated Hospital, School of Medicine at Zhejiang University
🇨🇳Hanzhou, Zhejiang, China