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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016366
Receipt No. 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

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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
Email 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
Email sg-kentaro@kf6.so-net.ne.jp

Sponsor
Institute Kokura Memorial Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018930

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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