UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021682
Receipt number 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 21:21:11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

HOT-VT study committee

Institute

Department

Personal name



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

Value
https://center6.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