UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040196 |
|---|---|
| Receipt number | R000045834 |
| Scientific Title | Utility of the earliest pulmonary vein potential-guided cryoballoon ablation for atrial fibrillation in a multicenter randomized study |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2024/10/22 16:40:57 |
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Basic information
Public title
Utility of the earliest pulmonary vein potential-guided cryoballoon ablation for atrial fibrillation in a multicenter randomized study
Acronym
Utility of the earliest pulmonary vein potential-guided cryoballoon ablation for atrial fibrillation in a multicenter randomized study
Scientific Title
Utility of the earliest pulmonary vein potential-guided cryoballoon ablation for atrial fibrillation in a multicenter randomized study
Scientific Title:Acronym
Utility of the earliest pulmonary vein potential-guided cryoballoon ablation for atrial fibrillation in a multicenter randomized study
Region
| Japan |
Condition
Condition
Paroxysmal atrial fibrillation
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate an utility of the earliest pulmonary vein potential-guided cryoballoon ablation for atrial fibrillation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence at 12 months after the ablation
Key secondary outcomes
Time to isolation of pulmonary vein potential, procedure time, cryoballoon ablation time, early recurrence...etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Pulmonary vein potential-guided cryoballoon ablation
Interventions/Control_2
Control group (conventional cryoballoon ablation)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with paroxysmal atrial fibrillation who are scheduled for cryoballoon ablation
Key exclusion criteria
-Persistent atrial fibrillation
-Impaired renal function/hemodialysis
-Common pulmonary vein anatomy
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | Toyoaki |
| Middle name | |
| Last name | Murohara |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.
TEL
81-52-744-2147
murohara@med.nagoya-u.ac.jp.
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Yanagisawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Advanced Cardiovascular Therapeutics
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.
TEL
81-52-744-2147
Homepage URL
yanagisawa-sato@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
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
Nagoya University Graduate School of Medicine Institutional Review Board
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.
Tel
81-52-744-2942
camcr@med.nagoya-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
市立四日市病院（三重県）、安城更生病院（愛知県）、名古屋市立大学病院（愛知県）、トヨタ記念病院（愛知県）、小牧市民病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | 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
124
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 | 04 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 19 | Day |
Last modified on
| 2024 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045834
