UMIN ID: UMIN000054628
Registered date:17/06/2024
Comparison of Invasively-measured and Echocardiography-derived Prosthesis-patient Mismatch Following Transcatheter Aortic Valve Replacement
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Aortic Stenosis |
| Date of first enrollment | 2024/06/17 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Right heart catheterization |
Outcome(s)
| Primary Outcome | Prosthesis-patient mismatch |
|---|---|
| Secondary Outcome | Hemodynamic indices, including effective orifice area, transvalvular mean pressure gradient, paravalvular regurgitation. Death (all-cause, cardiovascular, and non-cardiovascular). Readmission event (heart failure, pneumonia, bleeding event, etc.). Heart valve deterioration and thrombosis formation evaluated by transthoracic echocardiography and/or computed tomography. |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 110years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Patients who did not meet the criteria of technical success as defined by the Valve Academic Research Consortium 3 |
Related Information
| Primary Sponsor | St. Marianna University School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Japan Society for the Promotion of Science |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Taishi Okuno |
| Address | 2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, 216-8511, Kanagawa, Japan Japan 216-8511 |
| Telephone | 044-977-8111 |
| taishi.okuno@marianna-u.ac.jp | |
| Affiliation | St. Marianna University School of Medicine Department of Cardiology |
| scientific contact | |
| Name | Taishi Okuno |
| Address | 2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, 216-8511, Kanagawa, Japan Japan |
| Telephone | 044-977-8111 |
| taishi.okuno@marianna-u.ac.jp | |
| Affiliation | St. Marianna University School of Medicine Department of Cardiology |