Unique ID issued by UMIN | UMIN000031834 |
---|---|
Receipt number | R000035959 |
Scientific Title | Hemodynamic comparison of Trifecta and Resilia in the patients with severe aortic stenosis, small annulus, and low cardiac function |
Date of disclosure of the study information | 2018/04/01 |
Last modified on | 2018/03/22 10:42:00 |
Hemodynamic comparison of Trifecta and Resilia in the patients with severe aortic stenosis, small annulus, and low cardiac function
J-League trial
Hemodynamic comparison of Trifecta and Resilia in the patients with severe aortic stenosis, small annulus, and low cardiac function
J-League trial
Japan |
Aortic stenosis
Cardiovascular surgery |
Others
NO
Investigation of the function of bioproshtesis
Efficacy
peak pressure gradient at 1 year after implantation
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Device,equipment |
Trifecta
Resilia
60 | years-old | <= |
Not applicable |
Male and Female
1. Preoperative echo shows ejection fraction < 50%
2. Elective primary surgical aortic valve replacement
3. inclusion: concomitant CABG, tricuspid valve surgery,aand ascending aortic replacement
4. severe aortic stenosis (peak pressure gradient >64mmHg, mean pressure gradient>40mmHg, aortic valve area < 1.ocm2
5. Implanted valve size is expected to be 19-21mm (preoperative echo shows annulus diameter is smaller than 21mm).
6. Consent is obtained by documents from the patient.
1. concomitant mitral valve surgery
2. aortic root replacement
3. patients younger than 60 years
4. no preoperative echo data
5. emergency
6. patients with chronic hemodialysis
100
1st name | |
Middle name | |
Last name | Hiroshi Tanaka |
Kobe University, graduate school of medicine
Division of Surgery, Department of Cardiovascular surgery
7-5-1, Kusunokicho, Chuoku, Kobe
078-382-5942
hirtanak@med.kobe-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroshi Tanaka |
Kobe University, graduate school of medicine
Division of Surgery, Department of Cardiovascular surgery
7-5-1, Kusunokicho, Chuoku, Kobe
078-382-5942
hirtanak@med.kobe-u.ac.jp
Kobe University, graduate school of medicine, Division of Surgery, Department of Cardiovascular surgery
Abbott
Profit organization
NO
2018 | Year | 04 | Month | 01 | Day |
Unpublished
Preinitiation
2018 | Year | 03 | Month | 20 | Day |
2018 | Year | 05 | Month | 01 | Day |
2018 | Year | 03 | Month | 22 | Day |
2018 | Year | 03 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035959
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