UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011852 |
|---|---|
| Receipt number | R000013848 |
| Scientific Title | Catheter Ablation of Right Atrial Ganglionated Plexi in Patients with Supraventricular Tachycardia and Atrial Fibrillation |
| Date of disclosure of the study information | 2013/09/24 |
| Last modified on | 2013/09/24 18:01:43 |
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Basic information
Public title
Catheter Ablation of Right Atrial Ganglionated Plexi in Patients with Supraventricular Tachycardia and Atrial Fibrillation
Acronym
Catheter Ablation of Right Atrial Ganglionated Plexi in Patients with Supraventricular Tachycardia and Atrial Fibrillation
Scientific Title
Catheter Ablation of Right Atrial Ganglionated Plexi in Patients with Supraventricular Tachycardia and Atrial Fibrillation
Scientific Title:Acronym
Catheter Ablation of Right Atrial Ganglionated Plexi in Patients with Supraventricular Tachycardia and Atrial Fibrillation
Region
| Japan |
Condition
Condition
Atrial fibrillation, Suprarventricular tachycardia, Atrial flutter, WPWsyndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Research for the efficacy of the catheter ablation to atrial ganglionated plexi in atrial fibrillation patients with supraventricular tachycardia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Recurrence of atrial fibrillation and supraventricular tachycardia
Key secondary outcomes
Cardiovascular events, Administration of antiarrhythmic drugs, Shocks in patients with implantable cardioverter difibrillators
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Catheter ablation for right arterial ganglionated plexi in addition to ablation for WPW syndrome, superaventricular tachycardia or atrial flutter
Interventions/Control_2
Catheter ablation for right arterial ganglionated plexi
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who have a plan to be performed catheter ablation to WPW syndrome, atrial flutter, supraventricular tachycardia
2)Patients complicated with atrial fibrillation
3)more than or equal to 20 year old
4)Patients who consented to this clinical trial through the informed consent process in writing of the applicant.
Key exclusion criteria
1)A patient who did not consent to this clinical trial through the informed consent process in writing of the applicant.
2)The case in which the chief complaint is developed by atrial fibrillation.
3)Patients who participate in other clinical trials.
4)Patients who have a plan to be performed catheter ablation to left atrium.
5)Patients who underwent MAZE operation.
6)Atrial fibrillation responsible for the sympathetic nervous system. For example, induced by excise.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Marehiko Ueda |
Organization
Chiba-university hospital
Division name
The department of cardiovascular medicine
Zip code
Address
1-8-1 Inohana Chuo-ku Chiba-city Chiba-prefecture
TEL
043-222-7171
zta10540@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Ishimura |
Organization
Chiba-university hospital
Division name
The department of cardiovascular medicine
Zip code
Address
1-8-1 Inohana Chuo-ku Chiba-city Chiba-prefecture
TEL
090-3690-6511
Homepage URL
marnet0826@yahoo.co.jp
Sponsor or person
Institute
The department of cardiovascular medicine, Chiba university hospital
Institute
Department
Personal name
Funding Source
Organization
The department of cardiovascular medicine, Chiba university 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
| 2013 | Year | 09 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 09 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 24 | Day |
Last modified on
| 2013 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013848
