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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018863
Receipt No. R000021818
Scientific Title The Multicenter Prospective Randomized Controlled Trial Evaluating Efficacy of Ganglionic plexi (GP) Ablation in the Surgery for Atrial Fibrillation: Japan GP Ablation trial
Date of disclosure of the study information 2015/09/01
Last modified on 2019/09/10

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Basic information
Public title The Multicenter Prospective Randomized Controlled Trial Evaluating Efficacy of Ganglionic plexi (GP) Ablation in the Surgery for Atrial Fibrillation: Japan GP Ablation trial
Acronym J-GPA trial
Scientific Title The Multicenter Prospective Randomized Controlled Trial Evaluating Efficacy of Ganglionic plexi (GP) Ablation in the Surgery for Atrial Fibrillation: Japan GP Ablation trial
Scientific Title:Acronym J-GPA trial
Region
Japan

Condition
Condition Patients undergoing cardiac surgery
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess effectiveness of GP ablation in the atrial fibrillation surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Recurrence of atrial tachycardia and atrial fibrillation in 2 years.
Key secondary outcomes Recurrence of atrial tachycardia and atrial fibrillation, motality, and major adverse cardiac events in 6 months or 1 year.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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
Maneuver
Interventions/Control_1 Standardization of atrial fibrillation procedure
Interventions/Control_2 Standerdization of GP mapping and ablation technique.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients who have indication of atrial fibrillation surgery in the guidelines for non-pharmacotherapy of Cardiac Arrhythmias
Key exclusion criteria 1) Low cardiac function (EF<40%)
2) History of RFCA
3) Use of catechoramine
4) Thrombus in left atrial appendage
5) Pacemaker implantation
6) Non consent



Target sample size 300

Research contact person
Name of lead principal investigator
1st name Shun-ichiro
Middle name
Last name Sakamoto
Organization Nippon Medical School
Division name Department of Cardiovascular Surgery
Zip code 113-8603
Address 1-1-5 sendagi, Bunkyho-ku, Tokyo, Japan
TEL 03-5814-6219
Email saka-165@nms.ac.jp

Public contact
Name of contact person
1st name Shun-ichiro
Middle name
Last name Sakamoto
Organization Nippon Medical School
Division name Department of Cardiovascular Surgery
Zip code 113-8603
Address sendagi, Bunkyho-ku, Tokyo, Japan
TEL 03-5814-6219
Homepage URL http://arrhythm.umin.jp/for_doctors.html
Email saka-165@nms.ac.jp

Sponsor
Institute Department of Cariovascular Surgery, Nippon Medical School
Institute
Department

Funding Source
Organization Japan Society for Arrhythmia Surgery
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 Nippon Medical School
Address 1-1-3 sendagi, bunkyoku, tokyo, japan
Tel 03-3822-2131
Email saka-165@nms.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
2015 Year 09 Month 01 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
2013 Year 07 Month 31 Day
Date of IRB
2013 Year 07 Month 10 Day
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
2019 Year 03 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 31 Day
Last modified on
2019 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021818

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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