UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045351 |
|---|---|
| Receipt number | R000051335 |
| Scientific Title | Impact of Radiofrequency power settings on acute results of Ablation index-guided cavo-tricuspid isthmus ablation |
| Date of disclosure of the study information | 2021/09/15 |
| Last modified on | 2021/09/14 19:58:39 |
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Basic information
Public title
Impact of Radiofrequency power settings on acute results of Ablation index-guided cavo-tricuspid isthmus ablation
Acronym
Impact of Radiofrequency power settings on acute results of Ablation index-guided cavo-tricuspid isthmus ablation
Scientific Title
Impact of Radiofrequency power settings on acute results of Ablation index-guided cavo-tricuspid isthmus ablation
Scientific Title:Acronym
Impact of Radiofrequency power settings on acute results of Ablation index-guided cavo-tricuspid isthmus ablation
Region
| Japan |
Condition
Condition
Atrial flutter
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we compared different RF power application protocols for CTI ablation and evaluated the procedural impact of RF application power with the same target AI.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
First-pass conduction block rate of the CTI
Key secondary outcomes
periprocedural complication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The power settings were 35W
Interventions/Control_2
The power settings were 45W
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
We included the patients who were either undergoing CTI ablation for the treatment of isthmus-dependent AFL or CTI ablation as part of a procedure for the treatment of atrial fibrillation.
Key exclusion criteria
We also excluded patients who can not undergo contrast-enhanced 3D CT images.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Chikata |
Organization
Toyama Prefectural Central Hospital
Division name
Department of Cardiology
Zip code
930-8550
Address
2-2-78 Nishi-nagae, Toyama
TEL
076-424-1531
akio.chikata@gmail.com
Public contact
Name of contact person
| 1st name | Akio |
| Middle name | |
| Last name | Chikata |
Organization
Toyama Prefectural Central Hospital
Division name
Department of Cardiology
Zip code
930-855
Address
2-2-78 Nishi-nagae, Toyama
TEL
076-424-1531
Homepage URL
akio.chikata@gmail.com
Sponsor or person
Institute
Toyama Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyama Prefectural Central Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyama Prefectural Central Hospital
Address
2-2-78 Nishi-nagae, Toyama
Tel
076-424-1531
byoin@esp.pref.toyama.lg.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
| 2021 | Year | 09 | Month | 15 | 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
130
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 | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 02 | Day |
Last modified on
| 2021 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051335
