UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028984
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

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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 or person

Institute

Japan Agency for Medical Research and Development

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033130


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name