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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000022119
Receipt No. R000025392
Scientific Title Substrate Targeted Ablation of Persistent Atrial Fibrillation Trial
Date of disclosure of the study information 2016/07/14
Last modified on 2017/03/13

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Basic information
Public title Substrate Targeted Ablation of Persistent Atrial Fibrillation Trial
Acronym START Trial
Scientific Title Substrate Targeted Ablation of Persistent Atrial Fibrillation Trial
Scientific Title:Acronym START Trial
Region
Japan

Condition
Condition Persistent Atrial Fibrillation Patients
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Safety and efficacy of left atrial low voltage zone ablation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Acute teremination of atrisl fibrillation, long term success, and complications after left atrial low voltage zone ablation.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Pulmonary vein antrum isolation (PVAI) and Left atrial low voltage zone (LVZ) ablation for patients with LVZ.
Interventions/Control_2 PVAI only for patients with LVZ.
Interventions/Control_3 PVAI for patients without LVZ.
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 Persistent atrial fibrillation patient who is undergoing initial atrial fibrillation ablation.
Key exclusion criteria Patients with low cardiac function, left atrial thrombus, contraindication of anticoagulant therapy.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuchiya Takeshi
Organization EP Expert Doctors-Team Tsuchiya
Division name Electrophysiology
Zip code
Address Koto 3-14-28, Higashi-ku, Kumamoto
TEL 096-368-0403
Email tsuchiya0210jupiter@yj8.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fukui Akira
Organization EP Expert Doctors-Team Tsuchiya
Division name Electrophysiology
Zip code
Address Hirogi-machi 30-35-102, Higashi-ku, Kumamoto
TEL 090-2513-7156
Homepage URL
Email akira18@oita-u.ac.jp

Sponsor
Institute EP Expert Doctors-Team Tsuchiya
Institute
Department

Funding Source
Organization START Trial Meeting
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
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
2016 Year 07 Month 14 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
Date of protocol fixation
2015 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 30 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
2016 Year 04 Month 28 Day
Last modified on
2017 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025392

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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