UMIN-CTR Clinical Trial

Public title

Efficacy of Automated Ablation Annotation Algorithm(Visitag) in Reducing Re-conduction of Isolated Pulmonary Vein and Recurrence after Catheter Ablation for Atrial Fibrillation

Acronym

Efficacy of Automated Ablation Annotation Algorithm(Visitag) in Reducing Re-conduction of Isolated Pulmonary Vein and Recurrence after Catheter Ablation for Atrial Fibrillation

Scientific Title

Efficacy of Automated Ablation Annotation Algorithm(Visitag) in Reducing Re-conduction of Isolated Pulmonary Vein and Recurrence after Catheter Ablation for Atrial Fibrillation

Scientific Title:Acronym

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

Atrial Fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Koichi Inoue

Organization

Sakurabashi Watanabe Hospital

Division name

Cardiovascular center

Zip code

Address

2-4-32 Umeda, Kita, Osaka, Japan

TEL

06-6341-8655

Email

inoueko1@yahoo.co.jp

Name of contact person

1st name
Middle name
Last name	Nobuaki Tanaka

Organization

Sakurabashi Watanabe Hospital

Division name

Cardiovascular center

Zip code

Address

2-4-32 Umeda, Kita, Osaka, Japan

TEL

06-6341-8655

Homepage URL

Email

nob-t@tj9.so-net.ne.jp

Institute

Sakurabashi Watanabe Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

10

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2015

Year

10

Month

23

Day

Date of IRB

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

Other related information

Registered date

2015

Year

10

Month

29

Day

Last modified on

2017

Year

05

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022613