UMIN-CTR Clinical Trial

Basic information
Public title	A Prospective Observational Study Evaluating the Efficacy of an Induction Protocol of Ventricular Premature Complexes Originated from Outflow Tract in Catheter Ablation
Acronym	A Prospective Observational Study Evaluating the Efficacy of an Induction Protocol of Ventricular Premature Complexes Originated from Outflow Tract in Catheter Ablation
Scientific Title	A Prospective Observational Study Evaluating the Efficacy of an Induction Protocol of Ventricular Premature Complexes Originated from Outflow Tract in Catheter Ablation
Scientific Title:Acronym	A Prospective Observational Study Evaluating the Efficacy of an Induction Protocol of Ventricular Premature Complexes Originated from Outflow Tract in Catheter Ablation
Region	Japan

Condition
Condition	Ventricular arrhythmia
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the predictor of a procedural success in cahter ablation therapy for ventricular premature complexes originated from outflow tract
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	A predictor of a procedural success in cahter ablation therapy for ventricular premature complexes originated from outflow tract
Key secondary outcomes	1. A burden of premature ventricular complexes by each indcution protocol 2. A burden of premature ventricular complexes accoring to the origin of premature ventricular complexes 3. A predictor of the recurrence of premature ventricular complexes during follow up period 4. Relationship between the induction protocol and the burden or time with ventricular complexes 5. Adverse event by the induction protocols

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	1.Age older than 20 years 2.The patient is willing and able to comply with the protocol and has provided written informed consent
Key exclusion criteria	The patient who the investigators admit is not not appropriate to include in the study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masaya Middle name Last name Watanabe
Organization	Hokkaido University Hospital
Division name	Department of cardiovascular medicine
Zip code	060-8638
Address	North 15, West 7, Kita-ku, Sapporo city
TEL	0117066973
Email	m.watanabe@huhp.hokudai.ac.jp

Public contact
Name of contact person	1st name Masaya Middle name Last name Watanabe
Organization	Hokkaido University
Division name	Department of cardiovascular medicine
Zip code	060-8638
Address	North 15, West 7, Kita-ku, Sapporo city
TEL	0117066973
Homepage URL
Email	m.watanabe@huhp.hokudai.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Cardiovascular Medicine Hokkaido 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	Hokkaido University Hospital
Address	North 15, West 7, Kita-ku, Sapporo city
Tel	0117066973
Email	m.watanabe@huhp.hokudai.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	2022 Year 06 Month 25 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	Enrolling by invitation
Date of protocol fixation	2021 Year 11 Month 02 Day
Date of IRB	2021 Year 11 Month 02 Day
Anticipated trial start date	2021 Year 11 Month 26 Day
Last follow-up date	2033 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2022 Year 06 Month 25 Day
Last modified on	2022 Year 06 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054864