UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021139 |
|---|---|
| Receipt number | R000024383 |
| Scientific Title | Effectiveness of Adaptive Servo-Ventilation for severe aortic stenosis patients after aortic valve replacement |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2016/06/12 05:36:13 |
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Basic information
Public title
Effectiveness of Adaptive Servo-Ventilation for severe aortic stenosis patients after aortic valve replacement
Acronym
Effectiveness of ASV for severe AS patients after AVR
Scientific Title
Effectiveness of Adaptive Servo-Ventilation for severe aortic stenosis patients after aortic valve replacement
Scientific Title:Acronym
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)
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
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
| 1st name | |
| Middle name | |
| Last name | Yoshiki Sawa |
Organization
Osaka University Graduate School of Medicine
Division name
department of cardiovascular surgery
Zip code
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6789-3154
sawasec@surg1.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryohei Matsuura |
Organization
Osaka University Graduate School of Medicine
Division name
department of cardiovascular surgery
Zip code
Address
2-15, Yamadaoka, Suita, Osaka
TEL
06-6789-3154
Homepage URL
r-matsuura@surg1.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Date of protocol fixation
| 2016 | Year | 03 | Month | 09 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024383
