UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020270 |
|---|---|
| Receipt number | R000023401 |
| Scientific Title | Optimal force-time integral for pulmonary vein isolation according to anatomical wall thickness under the ablation line |
| Date of disclosure of the study information | 2015/12/20 |
| Last modified on | 2015/12/24 20:08:34 |
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Basic information
Public title
Optimal force-time integral for pulmonary vein isolation according to anatomical wall thickness under the ablation line
Acronym
Optimal FTI for AF ablation as per wall thickness
Scientific Title
Optimal force-time integral for pulmonary vein isolation according to anatomical wall thickness under the ablation line
Scientific Title:Acronym
Optimal FTI for AF ablation as per wall thickness
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the optimal CF or FTI for anatomical ipsilateral PVI based on LA wall thickness under the catheter ablation line.
Basic objectives2
Others
Basic objectives -Others
optimal value
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the optimal CF or FTI for anatomical ipsilateral PVI based on LA wall thickness under the catheter ablation line.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Symptomatic drug-refractory AF, referred to kanazawa medical center between September 2014 and August 2015 for RF catheter ablation for their first procedure.
2)Patients who underwent anatomical ipsilateral PVI and who were assessed for dormant conduction (DC) by an intravenous bolus of adenosine.
Key exclusion criteria
We excluded cases that required RF application in carina other than the PV antrum to achieve PV isolation.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Chikata |
Organization
National Hospital Organization, Kanazawa Medical Center
Division name
Department of Cardiology
Zip code
Address
1-1 shimoishibimki-machi, Kanazawa
TEL
076-262-4161
akio.chikata@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akio Chikata |
Organization
National Hospital Organization, Kanazawa Medical Center
Division name
Department of Cardiology
Zip code
Address
1-1 shimoishibimki-machi, Kanazawa
TEL
076-262-4161
Homepage URL
akio.chikata@gmail.com
Sponsor or person
Institute
National Hospital Organization, Kanazawa Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization, Kanazawa Medical Center
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
Address
Tel
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
独立行政法人国立病院機構金沢医療センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 20 | 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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
FTI, maximum CF, average CF, minimum CF, RF duration, and RF power were obtained for each ablation point.
The FTI for each ablation point was divided by the wall thickness of the PV atrium segment where the ablation point was located to calculate the ablation FTI required for every 1 mm of wall thickness (FTI/wall thickness).
Management information
Registered date
| 2015 | Year | 12 | Month | 18 | Day |
Last modified on
| 2015 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023401
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
