UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Substrate Targeted Ablation of Persistent Atrial Fibrillation Trial
Title of the study (Brief title)	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	Tsuchiya Takeshi
Organization	EP Expert Doctors-Team Tsuchiya
Division name	Electrophysiology
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	Fukui Akira
Organization	EP Expert Doctors-Team Tsuchiya
Division name	Electrophysiology
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2015 Year 07 Month 24 Day
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

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Publication of results	Unpublished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