Unique ID issued by UMIN | UMIN000012426 |
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Receipt number | R000014504 |
Scientific Title | A multicenter trial to assess transcatheter aortic valve replacement for chronic hemodialysis patients with aortic valve stenosis |
Date of disclosure of the study information | 2013/12/01 |
Last modified on | 2018/09/05 11:31:50 |
A multicenter trial to assess transcatheter aortic valve replacement for chronic hemodialysis patients with aortic valve stenosis
Transcatheter aortic valve replacement for chronic hemodialysis patients
A multicenter trial to assess transcatheter aortic valve replacement for chronic hemodialysis patients with aortic valve stenosis
Transcatheter aortic valve replacement for chronic hemodialysis patients
Japan |
Severe aortic valve stenosis
Chronic kidney disease (hemodialysis patients)
Cardiology | Cardiovascular surgery |
Others
NO
To assess the safety and efficacy of transcatheter aortic valve replacement in hemodialysis patients
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Improvement of heart failure symptoms more than 1 grade in the NYHA classification at the postoperative 1st year
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Edwards SAPIEN Transcatheter Heart Valve
Not applicable |
Not applicable |
Male and Female
1.Patients who have a high risk for operative mortality or are 'non-operable' as determined by cardiologist and cardiovascular surgeon
2.Severe aortic valve stenosis with the mean pressure gradient more than 40 mmHg, velocity more than 4.0 m/sec, or aortic valve area less than 0.8 cm2 by ultrasound cardiography
3.Heart failure symptoms with the NYHA classification greater than class II
4.Patient or substitute decision-maker signed the written informed consent, which had been approved by the institutional review board or its equivalence
5.Patient who is possible to visit on all follow-up days required after procedure
1. Acute myocardial infarction within 1 month
2. Unicuspid, bicuspid aortic valve, or aortic valve stenosis without calcification
3. Severe aortic valve regurgitation
4. Cardiac intervention within 2 weeks
5. Prior valve surgery with artifical valve ring or severe mitral valve regurgitation with level 3 or 4
6. Leukopenia, acute anemia, thrombocytopenic purpura, or past history of coagulation disorder
7. Coronary artery disease with significant stenosis requiring intervention.
8. Unstable circulation requiring mechanical support
9. Emergency procedure for any reason
10. Obstructive or nonobstructive cardiomyopathy
11. Severe LV dysfunction (LVEF<20%)
12. Cardiac tumor, thrombus, vegetation in UCG
13. Active gastrointestinal ulcer or history of upper gastrointestinal bleeding within 3 months
14. Allergy to aspirin, heparin, ticropigin, or contrast medium
15. Aortic valve annulus smaller than 18 mm or larger than 25 mm
16. CVA or TIA within 1 month
17. Life expectancy less than 12 months due to non-cardiac disease
18. Involvement in another clinical trial
19. Active bacterial endocarditis or other active infections
20. Massive calcified cusp of aortic valve close to the coronary ostium
21. Allergy to cobalt-chromium alloy
22. Abdominal or thoracic aortic aneurysm or atheroma (diameters more than 5 cm ), and serious denaturation or anatomical features of thoracoabdominal aorta
23. Severe calcification, extreme tortuosity and vessel diameter less than 6 mm making the safe insertion of sheath introducer impossible from the common iliac artery through the femoral artery
20
1st name | |
Middle name | |
Last name | Kazuaki Mitsudo |
Public interest incorporated foundation
Ohara HealthCare Foundation
Kurashiki Central Hospital
Heart Disease Center
1-1-1, Miwa, Kurashiki, Okayama
086-422-0210
kenkyu@kchnet.or.jp
1st name | |
Middle name | |
Last name | Harumi katoh |
Kurashiki Central Hospital
Department of Cardiology
1-1-1, Miwa, Kurashiki, Okayama
086-422-0210
kenkyu@kchnet.or.jp
Public interest incorporated foundation
Ohara HealthCare Foundation
Kurashiki Central Hospital
Heart Disease Center
Public interest incorporated foundation
Ohara HealthCare Foundation
Kurashiki Central Hospital
Department of Cardiology
Self funding
NO
2013 | Year | 12 | Month | 01 | Day |
Unpublished
Completed
2013 | Year | 10 | Month | 24 | Day |
2013 | Year | 12 | Month | 01 | Day |
2017 | Year | 12 | Month | 05 | Day |
2013 | Year | 11 | Month | 28 | Day |
2018 | Year | 09 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014504
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