UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Ethanol injection into Marshall vein during catheter ablation for atrial fibrillation
Title of the study (Brief title)	Ethanol injection into Marshall vein
Region	Japan

Condition
Condition	atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	feasibility, efficacy, safety evaluation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	success rate of ethanol injection, conduction block at the mitral isthmus
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	ethanol injection into Marshall vein
Interventions/Control_2
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 could not have conduction block at mitral isthmus.
Key exclusion criteria	Patients who do not have marshall vein
Target sample size	15

Research contact person
Name of lead principal investigator	Seiji Takatsuki
Organization	Keio University
Division name	Department of Cardiology
Address	35 Shinanomachi Shinjukuku
TEL	03-3353-1211
Email	seiji.takatsuki@gmail.com

Public contact
Name of contact person	Seiji Takatsuki
Organization	Keio University
Division name	Department of Cardiology
Address	35 Shinanomachi Shinjukuku
TEL	03-3353-1211
Homepage URL
Email	seiji.takatsuki@gmail.com

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Contribution
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	慶應義塾大学病院

Other administrative information
Date of disclosure of the study information	2014 Year 11 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2004 Year 11 Month 01 Day
Anticipated trial start date	2014 Year 11 Month 11 Day
Last follow-up date	2015 Year 11 Month 11 Day
Date of closure to data entry	2015 Year 12 Month 11 Day
Date trial data considered complete	2016 Year 06 Month 01 Day
Date analysis concluded	2016 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 11 Month 11 Day
Last modified on	2016 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018207