UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039258
Receipt number R000044390
Scientific Title Epidemiological study on the effectiveness and safety of catheter ablation: The Aomori Catheter Ablation Registry
Date of disclosure of the study information 2020/02/01
Last modified on 2023/01/28 12:30:11

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Basic information

Public title

Epidemiological study on the efficacy and safety of catheter ablation: The Aomori Catheter Ablation Registry

Acronym

The Aomori Catheter Ablation Registry

Scientific Title

Epidemiological study on the effectiveness and safety of catheter ablation: The Aomori Catheter Ablation Registry

Scientific Title:Acronym

The Aomori Catheter Ablation Registry

Region

Japan


Condition

Condition

Tachyarrhythmias

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine the success rate, prognosis, and acute and chronic complications of catheter ablation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Freedom from tachyarrhythmias at 1 year after catheter ablation

Key secondary outcomes

Perioperative complications
Cardiovascular complications and death during follow-up


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing catheter ablation at Hirosaki University hospital and Aomori prefectural hospital

Key exclusion criteria

none

Target sample size

5000


Research contact person

Name of lead principal investigator

1st name Masaomi
Middle name
Last name Kimura

Organization

Hirosaki University Graduate School of Medicine

Division name

Advanced Management of Cardiac Arrhythmias

Zip code

036-8216

Address

Zaifu-cho 5, Hirosaki City, Aomori, Japan

TEL

0172-33-5111

Email

masaomi@hirosaki-u.ac.jp


Public contact

Name of contact person

1st name Masaomi
Middle name
Last name Kimura

Organization

Hirosaki University Graduate School of Medicine

Division name

Advanced Management of Cardiac Arrhythmias

Zip code

036-8216

Address

Zaifu-cho 5, Hirosaki City, Aomori, Japan

TEL

0172-33-5111

Homepage URL


Email

masaomi@hirosaki-u.ac.jp


Sponsor or person

Institute

Hirosaki University

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Hirosaki University Hospital IRB

Address

Zaifu-cho 5, Hirosaki city, Aomori, Japan

Tel

0172-33-5111

Email

rinri@hirosaki-u.ac.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

2020 Year 02 Month 01 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

2020 Year 01 Month 26 Day

Date of IRB

2020 Year 04 Month 10 Day

Anticipated trial start date

2020 Year 08 Month 07 Day

Last follow-up date

2030 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational study


Management information

Registered date

2020 Year 01 Month 26 Day

Last modified on

2023 Year 01 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044390


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name