UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022272 |
|---|---|
| Receipt number | R000025664 |
| Scientific Title | A clinical study to evaluate the efficacy of radio frequency ablation and cryoballoon ablation on cardiac autonomic function - a randomized, parallel-group, open study - |
| Date of disclosure of the study information | 2016/05/11 |
| Last modified on | 2019/05/14 09:34:53 |
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Basic information
Public title
A clinical study to evaluate the efficacy of radio frequency ablation and cryoballoon ablation on cardiac autonomic function - a randomized, parallel-group, open study -
Acronym
A clinical study to evaluate the efficacy of radio frequency ablation and cryoballoon ablation on cardiac autonomic function - a randomized, parallel-group, open study -(R and B trial)
Scientific Title
A clinical study to evaluate the efficacy of radio frequency ablation and cryoballoon ablation on cardiac autonomic function - a randomized, parallel-group, open study -
Scientific Title:Acronym
A clinical study to evaluate the efficacy of radio frequency ablation and cryoballoon ablation on cardiac autonomic function - a randomized, parallel-group, open study -(R and B trial)
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of cryoballoon ablation on cardiac autonomic function of the paroxysmal atrial fibrillation patients stratified by heart failure, in comparison with RF ablation by MIBG, HRV, NGF-B
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of outcome of MIBG before and after treatment
Key secondary outcomes
1) The change of heart rate variability by Holter electrocardiogram
2)The relation between the change of NGF-B and the index of sympathetic nerve activation
3) The change of hs CRP/PINP/PIIINP
4) The relation between the recurrence within one year and primary outcomes (index predicting recurrence)
5) The relation between the index of sympathetic nerve activation and primary outcomes (including the intraoperative evaluation)
6) Pulmonary vein stenosis on CT
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Cryo ablation
Interventions/Control_2
RF ablation
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
1)Patients with paroxysmal atrial fibrillation
2)Patients who received sufficient explanation, understood it and gave written consent based on their free will, before participating in this study
Key exclusion criteria
1)Patients who undergo the treatment other than pulmonary vein isolation, complicated with atrial flutter or paroxysmal supraventricular tachycardia
2)Patients with severe mitral regurgitation or mitral stenosis after pacemaker implantation
3)Hemodialysis patients
4)Patients who are judged inappropriate by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Kawasaki |
Organization
Osaka General Medical Center
Division name
Department of Cardiology
Zip code
558-8558
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
kenkyusien@gh.opho.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Kawasaki |
Organization
Osaka General Medical Center
Division name
Department of Cardiology
Zip code
558-8558
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
Homepage URL
kenkyusien@gh.opho.jp
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Osaka General Medical Center
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
Tel
06-6692-1201
rinri@gh.opho.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
大阪府立急性期・総合医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 11 | Day |
Last modified on
| 2019 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025664
