UMIN-CTR Clinical Trial

Basic information
Public title	TAVR OPtimization baseD on the cost-Effectiveness AnaLysis
Acronym	TOPDEAL Study
Scientific Title	TAVR OPtimization baseD on the cost-Effectiveness AnaLysis
Scientific Title:Acronym	TOPDEAL Study
Region	Japan

Condition
Condition	Aortic Stenosis
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Quality-Adjusted Life Years (QALY) based on the QOL assessement EQ-5D.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	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.
Key exclusion criteria	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.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Toshihisa Middle name Last name Anzai
Organization	Hokkaido University School of Medicine
Division name	Cardiovascular Medicine
Zip code	0608638
Address	Kita 15, Nishi 7, Kita-ku, Sapporo,060-8638, Japan
TEL	011-706-6974
Email	anzai@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Amaki
Organization	National Cerebral and Cardiovascular Center
Division name	Division of Cardiovascular Medicine
Zip code	5648565
Address	6-1 Kishibe-Shimmachi, Suita, Osaka, 564-8565, Japan
TEL	06-6170-1070
Homepage URL
Email	amakimako@hotmail.com

Sponsor
Institute	Japan Agency for Medical Research and Development
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	ents > Department of Research Ethics and Bioethics Department of Research Ethics and Bioethics
Address	6-1 Kishibe-Shimmachi, Suita, Osaka, 564-8565, Japan
Tel	06-6170-1070
Email	rec-office-ac@ncvc.go.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 05 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	110
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 06 Month 30 Day
Date of IRB	2017 Year 07 Month 04 Day
Anticipated trial start date	2017 Year 09 Month 05 Day
Last follow-up date	2019 Year 12 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

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.

Management information
Registered date	2017 Year 09 Month 04 Day
Last modified on	2020 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033130