UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049804 |
|---|---|
| Receipt number | R000056718 |
| Scientific Title | A prospective study on changes in left atrial potential by cryoballoon ablation for left atrial roof region |
| Date of disclosure of the study information | 2022/12/16 |
| Last modified on | 2022/12/16 09:21:52 |
* 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
A prospective study on changes in left atrial potential by cryoballoon ablation for left atrial roof region
Acronym
A prospective study on changes in left atrial potential by cryoballoon ablation for left atrial roof region
Scientific Title
A prospective study on changes in left atrial potential by cryoballoon ablation for left atrial roof region
Scientific Title:Acronym
A prospective study on changes in left atrial potential by cryoballoon ablation for left atrial roof region
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in left atrial potential by cryoballoon ablation for left atrial roof region
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes in left atrial potential by cryoballoon ablation for left atrial roof region
Key secondary outcomes
inducibility of atrial tachyarrhythmias
information of cryoballoon ablation for left atrial roof region
left atrial potential in second catheter ablation
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 who underwent initial cryoballoon ablation for persistent atrial fibrillation
Key exclusion criteria
atypical anatomy of left atrium
severe chronic kidney disease
long standing persistent atrial fibrillation
age <20 years old
pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Matsuda |
Organization
Kansai Rosai Hospital
Division name
Cardiovascular Center
Zip code
660-8511
Address
3-1-69 Inabaso, Amagasaki, Hyogo
TEL
+81-6-6416-1221
matsuda-yasuhiro@kansaih.johas.go.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Matsuda |
Organization
Kansai Rosai Hospital
Division name
Cardiovascular Center
Zip code
660-8511
Address
3-1-69 Inabaso, Amagasaki, Hyogo
TEL
+81-6-6416-1221
Homepage URL
matsuda-yasuhiro@kansaih.johas.go.jp
Sponsor or person
Institute
Kansai Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Rosai Hospital Institutional Review Board
Address
3-1-69 Inabaso, Amagasaki, Hyogo
Tel
+81-6-6416-1221
chiken@kansaih.johas.go.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 | 12 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Patients who underwent initial cryoballoon ablation for persistent atrial fibrillation will be included.
Changes on left atrial potential by cryoballoon ablation for left atrial roof region will be mainly observed.
Management information
Registered date
| 2022 | Year | 12 | Month | 16 | Day |
Last modified on
| 2022 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056718
