JRCT ID: jRCT1030240157
Registered date:13/06/2024
Comparison of hemodynamics between Evolut and Sapien in transcatheter biological valves in dialysis patients
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Aortic valve stenosis |
| Date of first enrollment | 23/01/2024 |
| Target sample size | 200 |
| Countries of recruitment | |
| Study type | Observational |
| Intervention(s) | none |
Outcome(s)
| Primary Outcome | Hemodynamics of biological valves in the first postoperative year (effective valve opening area, blood flow velocity, and mean pressure gradient by echocardiography) |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | |
| Include criteria | Patients on hemodialysis for chronic kidney disease for at least 1 month as of the date of surgery. Have anatomical features suitable for TAVR using both Sapien and Evolut |
| Exclude criteria | Patients undergoing peritoneal dialysis for chronic kidney disease. Those who have undergone surgical aortic valve or transcatheter valve implantation. |
Related Information
| Primary Sponsor | Tabata Minoru |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Takeshi Kinoshita |
| Address | Bunkyo, Hongo 3-1-3 Tokyo Japan 1130033 |
| Telephone | +81-338133111 |
| t.kinoshita.pl@juntendo.ac.jp | |
| Affiliation | Juntendo University |
| Scientific contact | |
| Name | Minoru Tabata |
| Address | Bunkyo, Hongo 3-1-3 Tokyo Japan 1130033 |
| Telephone | +81-338133111 |
| minorutabata@juntendo.ac.jp | |
| Affiliation | Juntendo University |