UMIN-CTR Clinical Trial

Public title

Impact of Surround Flow Irrigation in Ablation Index-guided Pulmonary Vein Isolation: a Prospective Comparative Study on the Unexcitability during Ablation

Acronym

Impact of Surround Flow Irrigation in Ablation Index-guided Pulmonary Vein Isolation: a Prospective Comparative Study on the Unexcitability during Ablation

Scientific Title

Impact of Surround Flow Irrigation in Ablation Index-guided Pulmonary Vein Isolation: a Prospective Comparative Study on the Unexcitability during Ablation

Scientific Title:Acronym

Impact of Surround Flow Irrigation in Ablation Index-guided Pulmonary Vein Isolation: a Prospective Comparative Study on the Unexcitability during Ablation

Region

Japan

Condition

atrial fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Unlike the well-established ablation index (AI)-guided pulmonary vein isolation (PVI) using a ThermoCool SmartTouchTM (ST) catheter, safety and efficacy of using a ST Surround Flow (STSF) catheter equipped with entire tip irrigation system remain unclear. To investigate the impact of STSF, we compared the application time and AI for achieving unexcitability between STSF and ST ablation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

To investigate the impact of STSF, we compared the application time and AI for achieving unexcitability between STSF and ST ablation. Point-by-point ablation was performed during pacing by the ablation catheter at each 6 site along the left PVI line. The CF was adjusted to keep 10g. Radiofrequency (RF) energy at 30W was stopped immediately when the unexcitability to pace was achieved for three consecutive stimuli.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Point-by-point ablation was performed during pacing by the ablation catheter at each 6 site along the left PVI line. The CF was adjusted to keep 10g. Radiofrequency (RF) energy at 30W was stopped immediately when the unexcitability to pace was achieved for three consecutive stimuli. To investigate the impact of STSF, we compared the application time and AI for achieving unexcitability between STSF and ST ablation.

Interventions/Control_2

Point-by-point ablation was performed during pacing by the ablation catheter at each 6 site along the left PVI line. The CF was adjusted to keep 10g. Radiofrequency (RF) energy at 30W was stopped immediately when the unexcitability to pace was achieved for three consecutive stimuli. To investigate the impact of STSF, we compared the application time and AI for achieving unexcitability between STSF and ST ablation.

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

85

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) ability and willing to give written informed consent 2) paroxysmal and non-paroxysmal atrial fibrillation

Key exclusion criteria

1) age < 20 years 2) left ventricular ejection < 45% 3) left atrial diameter > 50 mm 4) significant valvular heart disease 5) reversible cause of AF 6) sustained or recurrent AF after the direct cardioversion 7) administration of amiodarone 8) intracardiac thrombus 9) inability to take anticoagulant

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Daisuke Horiuchi

Organization

Department of Cardiology, Hirosaki University Graduate School of Medicine

Division name

Advanced Management of Cardiac arrhythmias

Zip code

Address

5 Zaifu-Cho, Hirosaki, 036-8562 Japan

TEL

81-172-39-5056

Email

horiuch@hirosaki-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Daisuke Horiuchi

Organization

Department of Cardiology, Hirosaki University Graduate School of Medicine

Division name

Advanced Management of Cardiac arrhythmias

Zip code

Address

5 Zaifu-Cho, Hirosaki, 036-8562 Japan

TEL

81-172-39-5057

Homepage URL

Email

horiuch@hirosaki-u.ac.jp

Institute

Department of Cardiology, Hirosaki University Graduate School of Medicine

Institute

Department

Personal name

Organization

Department of Cardiology, Hirosaki University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Other

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

2017

Year

10

Month

11

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

Preinitiation

Date of protocol fixation

2017

Year

10

Month

10

Day

Date of IRB

Anticipated trial start date

2017

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

2017

Year

10

Month

10

Day

Last modified on

2017

Year

10

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033697