UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of Adaptive Servo-Ventilation for severe aortic stenosis patients after aortic valve replacement
Title of the study (Brief title)	Effectiveness of ASV for severe AS patients after AVR
Region	Japan

Condition
Condition	severe aortic stenosis
Classification by specialty	Cardiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to consider how effective the Adaptive-Servo Ventilator (ASV) is for severe aortic stenosis patients after aortic valve replacement.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	NYHA, 6-minute walk, Specific Activity Scale (24 weeks)
Key secondary outcomes	BNP, Dd, FS, EF, LVM (12, 24 weeks)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	to use ASV for 24 weeks after the surgery (everyday, more than 1 hour)
Interventions/Control_2	to observe without using ASV for 24 weeks after the surgery
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) patients who agree to participate in this study (2) severe aortic stenosis patients who will undergo aortic valve replacement (3) patients whose preoperative ejection fractions are over 50% (4) patients over 20 years old
Key exclusion criteria	(1) patients who will undergo the other valve surgery (2) patients who have chronic Af before surgery (3) patients who will undergo MAZE procedure (4) patients who are complicated with central sleep apnea rather than obstructive sleep apnea (5) Patients who are considered unsuitable to participate in the study than the researcher because of other reasons
Target sample size	20

Research contact person
Name of lead principal investigator	Yoshiki Sawa
Organization	Osaka University Graduate School of Medicine
Division name	department of cardiovascular surgery
Address	2-2, Yamadaoka, Suita, Osaka
TEL	06-6789-3154
Email	sawasec@surg1.med.osaka-u.ac.jp

Public contact
Name of contact person	Ryohei Matsuura
Organization	Osaka University Graduate School of Medicine
Division name	department of cardiovascular surgery
Address	2-15, Yamadaoka, Suita, Osaka
TEL	06-6789-3154
Homepage URL
Email	r-matsuura@surg1.med.osaka-u.ac.jp

Sponsor
Institute	Osaka university hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Philips
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	大阪大学医学部附属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 01 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 03 Month 09 Day
Anticipated trial start date	2016 Year 03 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 22 Day
Last modified on	2016 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024383