UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Automated Ablation Annotation Algorithm(Visitag) in Reducing Re-conduction of Isolated Pulmonary Vein and Recurrence after Catheter Ablation for Atrial Fibrillation
Title of the study (Brief title)	Efficacy of Automated Ablation Annotation Algorithm(Visitag) in Reducing Re-conduction of Isolated Pulmonary Vein and Recurrence after Catheter Ablation for Atrial Fibrillation
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to compare automatic annotation system with manual tag during CPVI using CARTO system and contact force catheter.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	recurrence of atrial fibrillation(1 year)
Key secondary outcomes	Spontaneous PV reconnection; Dormant conduction by ATP; duration of energy application ; total energy; procedure time; and complications associated with catheter ablation

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	RF Ablation using CARTO system. Manual collection of RF ablation points by assistant.
Interventions/Control_2	RF ablation was guided by an automated algorithm with predefined criteria of catheter stability range of motion; 1.5mm ,catheter stability duration ;5 seconds, and force over time (contact force;5g, time;25%). When this condition is satisfied, new tag appears. Tag size was 3mm and we intended to move catheter to next position to appear the new tag where was overlapped with the former tag. When force time integral (FTI) of the tag becomes 100-150gs, the color of tag changed from white to red and we moved catheter to the next position.
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 undergoing initial ablation for paroxysmal or persistent (duration < 5 year) atrial fibrillation
Key exclusion criteria	Patients with sustained atrial fibrillation episode 5 years or greater; Patients with left atrial size 50 mm or larger or left atrial volume 200ml or larger; Patients with valvular atrial fibrillation and a history of cardiac surgery; Patients age is < 20 years or 80 years or greater; Dialysis patients; Patients with heart failure (LVEF < 30% or NYHA class III or IV); Patients taking antiarrhythmic drugs before procedure; or Patients considered unsuitable for this study
Target sample size	150

Research contact person
Name of lead principal investigator	Koichi Inoue
Organization	Sakurabashi Watanabe Hospital
Division name	Cardiovascular center
Address	2-4-32 Umeda, Kita, Osaka, Japan
TEL	06-6341-8655
Email	inoueko1@yahoo.co.jp

Public contact
Name of contact person	Nobuaki Tanaka
Organization	Sakurabashi Watanabe Hospital
Division name	Cardiovascular center
Address	2-4-32 Umeda, Kita, Osaka, Japan
TEL	06-6341-8655
Homepage URL
Email	nob-t@tj9.so-net.ne.jp

Sponsor
Institute	Sakurabashi Watanabe Hospital
Institute
Department

Funding Source
Organization	none
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

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 30 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 10 Month 23 Day
Anticipated trial start date	2015 Year 11 Month 01 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	2015 Year 10 Month 29 Day
Last modified on	2017 Year 05 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022613