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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021682
Receipt No. R000024694
Scientific Title Investigation of the mechanism of polymorphic ventricular tachycardia originating above the pulmonary valve
Date of disclosure of the study information 2016/04/06
Last modified on 2018/01/26

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Basic information
Public title Investigation of the mechanism of polymorphic ventricular tachycardia originating above the pulmonary valve
Acronym HOT-VT: Hokkaido Outflow Tract Ventricular Tachycardia Study
Scientific Title Investigation of the mechanism of polymorphic ventricular tachycardia originating above the pulmonary valve
Scientific Title:Acronym HOT-VT: Hokkaido Outflow Tract Ventricular Tachycardia Study
Region
Japan

Condition
Condition Ventricular tachycardia, Premature ventricular complex
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is aimed to demonstrate the conduction disturbance at the ventriculo-arterial junction (VAJ) above the pulmonary valve.
Basic objectives2 Others
Basic objectives -Others Conductivity
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Changes in QRS morphology in response to rapid pacing (or extra-stimulus) at the VAJ and right ventricular outflow tract
Key secondary outcomes

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 undergoing catheter ablation for ventricular tachycardia / premature ventricular complex originating from right ventricular outflow tract or arrhythmias that require the use of 20-poles Lasso catheter for effective treatment
Key exclusion criteria Patients who were judged to be ineligible by a study investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi Yokoshiki
Organization Hokkaido University Hospital
Division name Cardiovascular Medicine
Zip code
Address Kita-14, Nishi-5, Kita-ku, Sapporo 060-8648, Japan
TEL 011-706-6973
Email yokoshh@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirofumi Mitsuyama
Organization Hokkaido University Hospital
Division name Cardiovascular Medicine
Zip code
Address Kita-14, Nishi-5, Kita-ku, Sapporo 060-8648, Japan
TEL 011-706-6973
Homepage URL
Email mitchy@med.hokudai.ac.jp

Sponsor
Institute HOT-VT study committee
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 北海道大学病院 Hokkaido University Hospital
北光記念病院 Hokko Memorial Hospital
国立病院機構北海道医療センターNational Hospital Organization Hokkaido Medical Center

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 06 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
Paper in preparation
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
2016 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 06 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 01 Month 31 Day

Other
Other related information Changes in QRS morphology in response to rapid pacing (or extra-stimulus) at the VAJ, right ventricular outflow tract and right ventricular apex

Case-control study

All the patients with inclusion criteria will be enrolled if they agree to participate in this study.

Management information
Registered date
2016 Year 03 Month 30 Day
Last modified on
2018 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024694

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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