UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of hemodynamic changes during balloon occlusion test for percutaneous atrial septal defect closure
Acronym	The balloon occlusion during ASD closure
Scientific Title	Investigation of hemodynamic changes during balloon occlusion test for percutaneous atrial septal defect closure
Scientific Title:Acronym	The balloon occlusion during ASD closure
Region	Japan

Condition
Condition	Atrial septal defect
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to clarify the relationship between the hemodynamic changes during balloon occlusion test and clinical events after percutaneous atrial septal defect closure
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary endpoint is the composite events including cardiac death, heart failure during hospitalization, heart failure after discharge , adjunctive diuretics, de novo palpitation and stroke after ASD closure.
Key secondary outcomes	Secondary endpoints New York Heart Assoission classification

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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	prospective observational study Significant left-to-right shunt, right ventricular (RV) volume overload, and/or clinical symptoms of heart failure or paradoxical embolism Atomically feasible for percutaneous ASD closure
Key exclusion criteria	Eisenmenger physiology
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Toshiro Middle name Last name Shinke
Organization	Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Zip code	650-0017
Address	7-5-2 Kusunokicho, Chuoku, Kobe-city, Hyogo
TEL	078-382-5111
Email	shinke@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Yamamoto
Organization	Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Zip code	650-0017
Address	7-5-2 Kusunokicho, Chuoku, Kobe-city, Hyogo
TEL	078-382-5846
Homepage URL
Email	y0493589m@hotmail.co.jp

Sponsor
Institute	Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
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	Kobe University Graduate School of Medicine
Address	7-5-2 Kusunokicho, Chuoku, Kobe-city, Hyogo
Tel	078-382-5846
Email	shinke@med.kobe-u.ac.jp

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 07 Month 31 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	Completed
Date of protocol fixation	2012 Year 07 Month 01 Day
Date of IRB	2013 Year 07 Month 01 Day
Anticipated trial start date	2012 Year 07 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study that examined the consecutive patients

Management information
Registered date	2016 Year 07 Month 31 Day
Last modified on	2020 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024488