UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021838
Receipt number R000025180
Scientific Title Chemical ablation using ethanol injection into the vein of Marshall for refractory atrial fibrillation and atrial tachycardia
Date of disclosure of the study information 2016/04/11
Last modified on 2021/10/15 13:47:26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Chemical ablation using ethanol injection into the vein of Marshall for refractory atrial fibrillation and atrial tachycardia

Acronym

Chemical ablation for atrial fibrillation and atrial tachycardia

Scientific Title

Chemical ablation using ethanol injection into the vein of Marshall for refractory atrial fibrillation and atrial tachycardia

Scientific Title:Acronym

Chemical ablation for atrial fibrillation and atrial tachycardia

Region

Japan


Condition

Condition

atrial fibrillation and atrial tachycardia

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Safety and efficacy of chemical ablation with ethanol injection into the vein of Marshall for atrial fibrillation and atrial tachycardia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Successful rate of achieving mitral block line, termination of atrial tachyarrhythmia.

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 the vein of Marshall

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

18 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with incomplete conduction block at mitral isthmus or patients with arrhythmogenicity around Marshall vein.

Key exclusion criteria

Patients who deny participating in this study or who were judged as inadequate.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Tetsuya
Middle name
Last name Haruna

Organization

The Tazukekofukai Medical Research Institute Kitano Hospital

Division name

Arrythmia section, Cardiovascular center

Zip code

5308480

Address

2-4-20, Ogimachi, Kitaku, Osaka City

TEL

06-6312-1221

Email

haruna@kitano-hp.or.jp


Public contact

Name of contact person

1st name Tetsuya
Middle name
Last name Haruna

Organization

The Tazukekofukai Medical Research Institute Kitano Hospital

Division name

Arrythmia section, Cardiovascular center

Zip code

5308480

Address

2-4-20, Ogimachi, Kitaku, Osaka City

TEL

06-6312-1221

Homepage URL


Email

haruna@kitano-hp.or.jp


Sponsor or person

Institute

The Tazukekofukai Medical Research Institute Kitano Hospital

Institute

Department

Personal name



Funding Source

Organization

The Tazukekofukai Medical Research Institute Kitano Hospital

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

Kitano Hospital Ethics Committee

Address

2-4-20, Ogimachi, Kitaku, Osaka City

Tel

06-6312-1221

Email

rinshou@kitano-hp.or.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

2016 Year 04 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

No longer recruiting

Date of protocol fixation

2016 Year 04 Month 08 Day

Date of IRB

2016 Year 04 Month 13 Day

Anticipated trial start date

2016 Year 04 Month 13 Day

Last follow-up date

2020 Year 04 Month 12 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 04 Month 08 Day

Last modified on

2021 Year 10 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025180


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name