UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054076 |
|---|---|
| Receipt number | R000061748 |
| Scientific Title | Combination therapy under high and very high power short duration ablation for the patients with atrial fibrillation: efficacy and safety evaluation |
| Date of disclosure of the study information | 2024/05/12 |
| Last modified on | 2025/10/19 15:23:00 |
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Basic information
Public title
Combination therapy under high and very high power short duration ablation: efficacy and safety evaluation
Acronym
Combination therapy under high and very high power short duration ablation: efficacy and safety evaluation
Scientific Title
Combination therapy under high and very high power short duration ablation for the patients with atrial fibrillation: efficacy and safety evaluation
Scientific Title:Acronym
Atrial fibrillation ablation using high and very high power ablation
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The cases of catheter ablation for atrial fibrillation is increasing. Therefore, there is a need for technology that enables shorter procedure time. In such situation, catheter which can able to ablate very high power (up to 90W) is available recently. However, it has been reported that initial line isolation-parameter of low AF recurrence-and safety evaluation might be lower than that of current ablation catheter. Some researcher suggested that combination usage under high and very high power may solve these problems. In spite of these suggestion, the efficacy and safety evaluation has still clarified yet.
The purpose of this study is to evaluate efficacy and safety evaluation using high and very high power ablation for the patients with atrial fibrillation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
evaluation of Initial line isolation
evaluation of stroke following catheter ablation
Key secondary outcomes
atrial fibrillation recurrence rate during 1 year follow-up period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
This group comprised of the patients who had undergone their first atrial fibrillation ablation using QDOT MICRO catheter under high and very high power ablation.
Interventions/Control_2
This group comprised of the patients who had undergone their first atrial fibrillation ablation using SMART TOUCH SF(current ablation catheter) catheter under high power 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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients who had undergone their first catheter ablation in our institution.
Key exclusion criteria
Patients who could not obtain informed consent.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Tsujita |
Organization
Department of Cardiovascular medicine, Kumamoto University Hospital
Division name
Cardiovascular medicine
Zip code
860-8556
Address
1-1-1 honjo kumamoto city
TEL
096-373-5175
tsujita@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Hoshiyama |
Organization
Department of Cardiovascular medicine, Kumamoto University Hospital
Division name
Cardiovascular medicine
Zip code
860-8556
Address
1-1-1 honjo Kumamoto city
TEL
096-373-5175
Homepage URL
tadashi@kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular medicine, Kumamoto University Hospital
Institute
Department
Personal name
Tadashi Hoshiyama
Funding Source
Organization
There are no funding source related to this investigation.
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
Kumamoto University Hospital
Address
1-1-1 honjo Kumamoto city
Tel
096-373-5966
byi-senshin@jimu.kumamoto-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
| 2024 | Year | 05 | Month | 12 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 01 | 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
| 2024 | Year | 04 | Month | 05 | Day |
Last modified on
| 2025 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061748
