Unique ID issued by UMIN | UMIN000028984 |
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Receipt number | R000033130 |
Scientific Title | TAVR OPtimization baseD on the cost-Effectiveness AnaLysis |
Date of disclosure of the study information | 2017/09/05 |
Last modified on | 2020/03/07 09:20:16 |
TAVR OPtimization baseD on the cost-Effectiveness AnaLysis
TOPDEAL Study
TAVR OPtimization baseD on the cost-Effectiveness AnaLysis
TOPDEAL Study
Japan |
Aortic Stenosis
Cardiology |
Others
NO
Transcatheter aortic valve replacement (TAVR) techniques have demonstrated to be a feasible alternative therapy to surgical aortic valve replacement. However, previous report demonstrated high readmitting rate for heart failure (HF) despite TAVR treatment. The determinant of recurrent HF has not been fully investigated. Our objective is to elucidate the risk factor of the patient who produce heart failure after TAVR and to investigate the cost effectiveness of TAVR treatment.
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
Quality-Adjusted Life Years (QALY) based on the QOL assessement EQ-5D.
Observational
Not applicable |
Not applicable |
Male and Female
1) Aortic Stenosis (maximal trans-aortic velocity>=4m/sec, mean gradient > 40mmHg, or an aortic valve area (AVA) of < 1.0 cm2 or AVA index < 0.6 cm2/m2)
2) Symptomatic due to aortic valve stenosis as demonstrated by NYHA Functional Class >= II.
3)STS score>4% or the subject, after formal consults by a cardiologist and two cardiovascular surgeons agreed that medical factors precluding operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeded the probability of meaningful improvement.
4)No valvular heart disease other than aortic stenosis.
1)Untreated clinically significant coronary artery disease requiring revascularization.
2)Atrial fibrillation
3)History of open heart surgery.
4)Unable to obtain written informed consent.
5)Clinical Frailty Scale>7
6)Severe ventricular dysfunction with LVEF < 20%.
7)Native aortic annulus size < 18mm or > 25mm as measured by echocardiogram.
8)Evidence of an acute myocardial infarction <= 1 month before the intended treatment.
9)Aortic valve was a congenital unicuspid or congenital bicuspid valve, or was non-calcified.
10)Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic
regurgitation >3+).
11)Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices.
12)Need for emergency surgery for any reason.
13)Hypertrophic cardiomyopathy with or without obstruction.
14)Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months.
15)Recent (within 6 months) cerebrovascular accident or transient ischemic attack.
16)Life expectancy < 12 months due to non-cardiac co-morbid conditions.
17)Bulky calcified aortic valve leaflets near proximity to coronary ostia.
100
1st name | Toshihisa |
Middle name | |
Last name | Anzai |
Hokkaido University School of Medicine
Cardiovascular Medicine
0608638
Kita 15, Nishi 7, Kita-ku, Sapporo,060-8638, Japan
011-706-6974
anzai@med.hokudai.ac.jp
1st name | Makoto |
Middle name | |
Last name | Amaki |
National Cerebral and Cardiovascular Center
Division of Cardiovascular Medicine
5648565
6-1 Kishibe-Shimmachi, Suita, Osaka, 564-8565, Japan
06-6170-1070
amakimako@hotmail.com
Japan Agency for Medical Research and Development
Japan Agency for Medical Research and Development
Japanese Governmental office
ents > Department of Research Ethics and Bioethics Department of Research Ethics and Bioethics
6-1 Kishibe-Shimmachi, Suita, Osaka, 564-8565, Japan
06-6170-1070
rec-office-ac@ncvc.go.jp
NO
2017 | Year | 09 | Month | 05 | Day |
Unpublished
110
No longer recruiting
2017 | Year | 06 | Month | 30 | Day |
2017 | Year | 07 | Month | 04 | Day |
2017 | Year | 09 | Month | 05 | Day |
2019 | Year | 12 | Month | 10 | Day |
We will develop prognostic model to predict no improvement of QOL and heart failures after TAVR. Strain measurements from echo-cardiogram will be assessed to develop the model. We will prospectively enroll 100 patients with severe aortic stenosis. Patients follow up will be done until 1 year after TAVR procedure. We will also do cost-effectiveness analysis with using results of this study. Cost-effectiveness analysis will be processed by Markov model. We will estimate the incremental cost-effectiveness ratio (ICER) of TAVR compared with standard therapy among inoperable patients with severe aortic stenosis. We will also perform the cost-effectiveness analysis of patients' selection based on our prognostic model.
2017 | Year | 09 | Month | 04 | Day |
2020 | Year | 03 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033130
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