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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023592
Receipt No. R000026741
Scientific Title Epicardial catheter ablation using the pericardial endoscopy
Date of disclosure of the study information 2016/08/22
Last modified on 2018/02/10

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Basic information
Public title Epicardial catheter ablation using the pericardial endoscopy
Acronym Epicardial catheter ablation using the pericardial endoscopy
Scientific Title Epicardial catheter ablation using the pericardial endoscopy
Scientific Title:Acronym Epicardial catheter ablation using the pericardial endoscopy
Region
Japan

Condition
Condition Ventricular tachycardia
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of pericardial endoscopy as a tool for noninvasive cardiac surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety of the use of percardial endoscopy in the pericardial space
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The use of pericardial endoscope in the pericardial space
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
75 years-old >=
Gender Male
Key inclusion criteria Patients indicated for the epicardial catehter ablation
Key exclusion criteria <20 or >75 years old
Post cardiac surgery
Hemodynamic instability
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiji Takatsuki
Organization Keio University School of Medicine
Division name Department of Cardiology
Zip code
Address 35 Shinanomachi Shinjuku-ku Tokyo
TEL 03-3353-1211
Email seiji.takatsuki@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takehiro Kimura
Organization Keio University School of Medicine
Division name Department of Cardiology
Zip code
Address 35 Shinanomachi Shinjuku-ku Tokyo
TEL 03-3353-1211
Homepage URL
Email kimura@z7.keio.jp

Sponsor
Institute Keio University School of Medicine
Department of Cardiology
Institute
Department

Funding Source
Organization Keio University School of Medicine
Department of Cardiology
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 08 Month 22 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 Terminated
Date of protocol fixation
2011 Year 03 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 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 08 Month 10 Day
Last modified on
2018 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026741

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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