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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024698
Receipt No. R000028416
Scientific Title Three-Dimensional Transesophageal Echocardiography to Assess Right Ventricular Function by Pressure-Volume Loops during Left Ventricular Assist Device Surgery
Date of disclosure of the study information 2016/11/10
Last modified on 2018/05/21

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Basic information
Public title Three-Dimensional Transesophageal Echocardiography to Assess Right Ventricular Function by Pressure-Volume Loops during Left Ventricular Assist Device Surgery
Acronym Three-Dimensional Transesophageal Echocardiography to Assess Right Ventricular Function by Pressure-Volume Loops during Left Ventricular Assist Device Surgery
Scientific Title Three-Dimensional Transesophageal Echocardiography to Assess Right Ventricular Function by Pressure-Volume Loops during Left Ventricular Assist Device Surgery
Scientific Title:Acronym Three-Dimensional Transesophageal Echocardiography to Assess Right Ventricular Function by Pressure-Volume Loops during Left Ventricular Assist Device Surgery
Region
Japan

Condition
Condition Severe heart failure requiring left ventricular assist device
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the shapes of RV pressure-volume loops and RV stroke works between before and after equipping left ventricular assist device.
Basic objectives2 Others
Basic objectives -Others We will assess right ventricular function by three-dimensional transesophageal echocardiography during left ventricular assist device surgery to construct new diagnostic criteria for right heart failure requiring right ventricular assist device.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Right ventricular stroke work, right ventricular stroke work index
Key secondary outcomes right ventricular ejection fraction, right ventricular end-diastolic volume index, right ventricular end-systolic volume index, right ventricular stroke volume/right ventricular end-systolic volume

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients requiring left ventricular assist device
Key exclusion criteria contraindications of transesophageal echocardiography,
atrial fibrillation,
patients who have been equipped with PCPS ,
not obtained informed consent
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Yoshitani
Organization National Cerebral and Cardiovascular Center
Division name Department of Anesthesioogy
Zip code
Address 5-7-1 Fujishirodai, Suita, Osaka
TEL 06-6833-5012
Email sohtamikaze@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Eiki Kanemaru
Organization National Cerebral and Cardiovascular Center
Division name Department of Anesthesioogy
Zip code
Address 5-7-1 Fujishirodai, Suita, Osaka
TEL 06-6833-5012
Homepage URL
Email eiki-k.16@hotmail.co.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 11 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2016 Year 08 Month 09 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 26 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information We will also collect conventional data such as TAPSE(tricuspid annular plane systolic excursion), RVFAC(right ventricular fractional area change) and severity of TR.

Management information
Registered date
2016 Year 11 Month 03 Day
Last modified on
2018 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028416

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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