Aortic Valve Stenosis
Conditions
Keywords
transcatheter aortic valve Replacement
Brief summary
The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve Replacement (TAVR) in the Asian Pacific population
Interventions
DEVICETranscatheter aortic valve Replacement
Sponsors
Asan Medical Center
Cardiovascular Clinical Research
Michael Kang-Yin Lee, MD
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses. * The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death from any cause | 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke | 1 month | — |
| Myocardial infarction | 1 month | — |
| Repeat hospitalization | 1 month | — |
| Death from cardiac cause | 1 month | — |
| Vascular complication | 1 month | — |
| Bleeding events | 1 month | — |
| Device success | 1 month | 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) |
| Acute kidney injury | 1 month | — |
Countries
China, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand
Contacts
Primary ContactElly Jeong-youn Bae, Research Nurse
Outcome results
None listed