UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Evaluation of Prosthetic Valve in Patients with Aortic Stenosis
Acronym	Clinical Evaluation of Prosthetic Valve in Patients with Aortic Stenosis
Scientific Title	Clinical Evaluation of Prosthetic Valve in Patients with Aortic Stenosis
Scientific Title:Acronym	Clinical Evaluation of Prosthetic Valve in Patients with Aortic Stenosis
Region	Japan

Condition
Condition	Aortic Stenosis
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Aortic valve replacement (AVR) ia a most common therapy for aortic stenosis (AS). It is a major problem that Japanese people have smaller annuluses than European. Because their annuluses is small, conventional AVR cannot release left ventricular outlet tract obstruction (LVOTO) and improve left ventricular function. Therefore, root enlarging or placing the valve partly in a supraannular position is often performed, however it is difficult in some cases. Patient-prosthesis mismatch(PPM) is defined that after valve replacement operation the effective orifice area (EOA) of prosthetic valve is smaller than the native valve. According to this definition, in the case that no prohstetic valve has same orifice area to the normal aortic valve, PPM occurs in all patients after operations. However, PPM is not intercorrelate with the size of prosthetic valve but also with body surface area(BSA), therefore the effective orifice area index(EOAI), that is defined as EOA of the prosthetic valve devided by BSA, are used in evaluating the PPM. We have examined how the PPM effect clinically in AVR, however it is not clear. In this study, We examine whether ATS 16AP that is the smallest prosthetic valve in the world avoids the PPM.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	postoperative cardiac function
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	a
Key exclusion criteria	a
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Yoshikatsu Saiki
Organization	Graduate school of medicine
Division name	Division of Cardiovascularsurgery
Zip code
Address	Seiryo1-1,Aoba ward, Sendai city
TEL	022-717-7222
Email	yoshisaiki@med.tohoku.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Ko Sakatsume
Organization	Graduate school of medicine
Division name	Division of Cardiovascularsurgery
Zip code
Address	Seiryo1-1,Aoba ward, Sendai city
TEL	022-717-7222
Homepage URL
Email	kosakatsume@gmail.com

Sponsor
Institute	Division of Cardiovascular Surgery, TOHOKU University Graduate school of medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2015 Year 10 Month 19 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
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	Completed
Date of protocol fixation	2015 Year 09 Month 01 Day
Date of IRB	2014 Year 09 Month 16 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date	2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is a multicenter trial in Tohoku University Hospital and the other hospitals. We examine the cases of AVR performed from January 2008 to August 2015 with ATS16AP. We collect and evaluate the data related to the prognosis and the results of UCG.

Management information
Registered date	2015 Year 10 Month 19 Day
Last modified on	2019 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022016