UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018863 |
|---|---|
| Receipt number | 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 | 2022/10/04 18:34:15 |
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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
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
saka-165@nms.ac.jp
Sponsor or person
Institute
Department of Cariovascular Surgery, Nippon Medical School
Institute
Department
Personal name
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
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
https://pubmed.ncbi.nlm.nih.gov/35476249/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35476249/
Number of participants that the trial has enrolled
69
Results
After a mean follow-up period of 16.3 months, Kapla-Meier atrial fbrillation-free curves showed no significant diference between the two groups(P=.685).
Cox proportional hazards regression analysis indicated that left atrial dimension was the only risk factor for atrial fbrillation
recurrence (hazard ratio: 1.106, 95% confidence interval 1.017-1.024, P=.019).
Results date posted
| 2022 | Year | 10 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eligible patients were aged 20 to 70 years who required surgical treatment of AF associated with the structural disease
Participant flow
A total of 74 patients were enrolled in this study. Sixty nine patients completed the study, whereas fve patients were excluded because of a cancelled operation (n=3) or trial dropout (n=2).The intention-to-treat analysis included 69 patients (34 in the ganglionated plexi ablation group and 35 in the maze
group).
Adverse events
There were no apparent adverse clinical events associated with the enrollment in the study.
Outcome measures
The primary endpoint was a recurrence of AF or atrial tachycardia (AT) postoperatively for a maximum of 2 years.
The secondary end　points were risk factor analysis for recurrence of AF or AT,
the occurrence of major adverse cardiac or cerebrovascular events, and pacemaker implantation rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021818
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