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 |
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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) |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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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 |
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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 |