Aortic Valve Insufficiency, Heart Valve Diseases
Conditions
Keywords
TAVR, TAVI, real-world
Brief summary
This registry evaluates the long-term outcome of Transcatheter aortic valve replacement (TAVR) in real-world clinical practice.
Detailed description
This study is connected with Asian TAVR registry(NCT02308150). Some subjects from Asian TAVR registry continue 10 years follow-up on this TP-TAVR registry.
Interventions
PROCEDURETAVR
transcatheter aortic valve replacement (TAVR)
Sponsors
CardioVascular Research Foundation, Korea
Duk-Woo Park, MD
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Inclusion criteria
* All patients undergoing TAVR * Informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event rate of all cause death | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NYHA class | 30 days | — |
| Event rate of Vascular access site and access-related complication | 30 days | according to Valve Academic Research Consortium (VARC) criteria |
| Event rate of cardiovascular death | 10 years | A. Death due to proximate cardiac cause B. Death caused by non-coronary vascular condition C. All procedure-related death D. All valve-related death E. Sudden or unwitnessed death F. Death of unknown cause |
| Event rate of myocardial infarction | 10 years | according to Valve Academic Research Consortium (VARC) criteria |
| Event rate of cerebrovascular accident | 10 years | stroke and TIA (Transient Ischemic Attack) |
| Event rate of bleeding | 10 years | according to Valve Academic Research Consortium (VARC) criteria |
| Event rate of Structural valve deterioration | 10 years | — |
| Event rate of Permanent pacemaker insertion | 10 years | — |
| Event rate of Other TAVR-related complication | 10 years | A. Conversion to open surgery B. Coronary obstruction C. Mitral valve apparatus damage or dysfunction D. Cardiac tamponade E. Endocarditis F. Valve thrombosis G. Valve mal-positioning H. TAV-in-TAV deployment |
| Event rate of Prosthetic valve dysfunction | 10 years | according to Valve Academic Research Consortium (VARC) criteria A. Prosthetic aortic valve stenosis B. Prosthesis-patient mismatch C. Prosthetic aortic valve regurgitation |
| Event rate of Composite endpoint | 10 years | A. Device success B. Early safety : death, cerebrovascular event, fatal bleeding, acute kidney injury, coronary obstruction requiring intervention, major vascular complication, valve dysfunction requiring intervention C. Clinical efficacy : death, cerebrovascular event, valve-related symptom requiring hospitalization or devastating heart failure, NYHA class\* III, IV dyspnea, valve dysfunction \*the New York Heart Association (NYHA) Functional Classification |
| Valve area | 1 year | — |
| Event rate of free from atrial fibrillation | 10 years | — |
| Event rate of Acute kidney injury | 30 days | — |
Countries
China, South Korea, United States
Contacts
Primary ContactDuk-woo Park, MD
Backup ContactDo-yoon Kang, MD
Outcome results
None listed