UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048167 |
|---|---|
| Receipt number | R000054864 |
| Scientific Title | A Prospective Observational Study Evaluating the Efficacy of an Induction Protocol of Ventricular Premature Complexes Originated from Outflow Tract in Catheter Ablation |
| Date of disclosure of the study information | 2022/06/25 |
| Last modified on | 2022/06/25 17:11:06 |
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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
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
m.watanabe@huhp.hokudai.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054864
