UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042325 |
|---|---|
| Receipt number | R000048315 |
| Scientific Title | The comparison of voltage guide and non-voltage guide PVI in patients with atrial fibrillation. |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2023/05/08 07:18:32 |
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Basic information
Public title
The comparison of voltage guide and non-voltage guide PVI in patients with atrial fibrillation.
Acronym
The comparison of voltage guide and non-voltage guide PVI in patients with atrial fibrillation.
Scientific Title
The comparison of voltage guide and non-voltage guide PVI in patients with atrial fibrillation.
Scientific Title:Acronym
The comparison of voltage guide and non-voltage guide PVI in patients with atrial fibrillation.
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of voltage guide PVI in atrial fibrillation ablation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The recurrence rate of atrial fibrillation in one year.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
To perform voltage guide PVI
Interventions/Control_2
To perform non-voltage guide PVI
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
To perform 1st session of PVI
Key exclusion criteria
To have previous AF ablation
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Kishihara |
Organization
Kitasato university school of medicine
Division name
Department of cardiovascular medicine
Zip code
2520374
Address
Kitasato1-15-1, Minami-ku, Sagamihara, JAPAN
TEL
042-778-8111
j_kishihara@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Kishihara |
Organization
Kitasato university school of medicine
Division name
Department of cardiovascular medicine
Zip code
2520374
Address
Kitasato1-15-1, Minami-ku, Sagamihara, JAPAN
TEL
042-778-8111
Homepage URL
j_kishihara@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato university
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
The institutional ethics committee of hospital of the Kitasato University School of Medicine.
Address
Kitasato1-15-1, Minami-ku, Sagamihara, JAPAN
Tel
042-7778-8111
rinrib@med.kitasato-u.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
昭和大学横浜市北部病院（神奈川県）、聖マリアンナ医科大学横浜市西部病院（神奈川県）、仙台厚生病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 01 | 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
342
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
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 02 | Day |
Last modified on
| 2023 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048315
