UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016366 |
|---|---|
| Receipt number | R000018930 |
| Scientific Title | The Impact of Focal Ablation in Catheter Ablation of Paroxysmal Atrial Fibrillation |
| Date of disclosure of the study information | 2015/01/29 |
| Last modified on | 2015/01/28 19:07:49 |
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Basic information
Public title
The Impact of Focal Ablation in Catheter Ablation of Paroxysmal Atrial Fibrillation
Acronym
The importance of detecting any non-PV foci and eliminating them during Paroxysmal Atrial Fibrillation ablation
Scientific Title
The Impact of Focal Ablation in Catheter Ablation of Paroxysmal Atrial Fibrillation
Scientific Title:Acronym
The importance of detecting any non-PV foci and eliminating them during Paroxysmal Atrial Fibrillation ablation
Region
| Japan |
Condition
Condition
Paroxysmal atrial fibrillation (PAF)
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of catheter ablation aimed at eliminating the AF foci of PAF including non-PV foci.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AF recurrence-free rate of AF
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Three hundred and four consecutive patients with drug-refractory, symptomatic PAF who underwent their first catheter ablation procedure between September 2009 and June 2011 were included in the study.
Key exclusion criteria
Patients who had previously experienced AF lasting more than 24 hours, had severe structural abnormalities, or dropped out of follow-up after the procedure were excluded from the study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Hayashi |
Organization
Kokura Memorial Hospital
Division name
Department of Cardiology
Zip code
Address
Asano 3-2-1,Kokurakita-ku,Kitakyushu,Japan
TEL
093-511-2000
sg-kentaro@kf6.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Hayashi |
Organization
Kokura Memorial Hospital
Division name
Department of Cardiology
Zip code
Address
Asano 3-2-1,Kokurakita-ku,Kitakyushu,Japan
TEL
093-511-2000
Homepage URL
sg-kentaro@kf6.so-net.ne.jp
Sponsor or person
Institute
Kokura Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Kokura Memorial Hospital
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 29 | 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 | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | 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
We included 304 consecutive patients undergoing CA for PAF (209 males, aged 63.0 +/- 10.4 years). We divided the patients into 3 groups: group 1 comprised 245 patients without any inducible non-PV triggers; group 2 comprised 34 patients with AF originating from non-PV triggers with all non-PV triggers successfully ablated; and group 3 comprised 25 patients with AF originating from non-PV triggers with unsuccessful complete elimination of the non-PV triggers, and inducibility of AF or frequent ectopic beats still present. The mean follow up period was 26.9 +/- 11.8 months, and we compare the recurrence rate of AF after the last procedure.
Management information
Registered date
| 2015 | Year | 01 | Month | 28 | Day |
Last modified on
| 2015 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018930
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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