UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041033 |
|---|---|
| Receipt number | R000046607 |
| Scientific Title | Relationship between recurrence and exposure in catheter ablation of atrial fibrillation |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2022/07/16 14:29:29 |
* 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
Relationship between recurrence and exposure in catheter ablation of atrial fibrillation
Acronym
AF ablation and exposure
Scientific Title
Relationship between recurrence and exposure in catheter ablation of atrial fibrillation
Scientific Title:Acronym
AF ablation and exposure
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigation the recurrence, exposure and safety rate of patients underwent catheter ablation of atrial fibrillation between the contrast CT and the non-contrast CT group.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was the recurrence of AF or other atrial tachy-arrhythmia. Observational period was set at 2 year after the index ablation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
| Device,equipment |
Interventions/Control_1
Contrast CT group
Interventions/Control_2
Non contrast CT group
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
AF patients with indication for catheter ablation by Japanese Circulation Society guideline.
Key exclusion criteria
Renal dysfunction or allergy of contrast
BNP > 1000 pg/ml
Left atrium diameter > 55mm
Target sample size
340
Research contact person
Name of lead principal investigator
| 1st name | Naruya |
| Middle name | |
| Last name | Ishizue |
Organization
Kitasato University School of Medicine
Division name
Cardiovascular medicine
Zip code
2520374
Address
Minamiku Kitasato 1-15-1, Sagamihara
TEL
042427788111
n_ishizue@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Naruya |
| Middle name | |
| Last name | Ishizue |
Organization
Kitasato University School of Medicine
Division name
Cardiovascular Medicine
Zip code
2520374
Address
Minamiku Kitasato 1-15-1, Sagamihara
TEL
0427788111
Homepage URL
n_ishizue@med.kitasato-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Kitasato University School of Medicine.
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
The Ethics Committee of Kitasato University hospital
Address
Minamiku Kitasato 1-15-1, Sagamihara
Tel
0427788111
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | 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
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
Preinitiation
Date of protocol fixation
| 2020 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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 | 07 | Month | 08 | Day |
Last modified on
| 2022 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046607
