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Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011852
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email marnet0826@yahoo.co.jp

Sponsor
Institute The department of cardiovascular medicine, Chiba university hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013848


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