TAVR OPtimization baseD on the cost-Effectiveness AnaLysis

TAVR OPtimization baseD on the cost-Effectiveness AnaLysis - TOPDEAL Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000028984

Enrollment

100

Registered

2017-09-05

Start date

2017-09-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Quality-Adjusted Life Years (QALY) based on the QOL assessement EQ-5D.	—

Countries

Japan

Contacts

Public ContactMakoto Amaki

National Cerebral and Cardiovascular Center Division of Cardiovascular Medicine

amakimako@hotmail.com06-6170-1070

Outcome results