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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029499
Receipt No. R000033697
Scientific Title Impact of Surround Flow Irrigation in Ablation Index-guided Pulmonary Vein Isolation: a Prospective Comparative Study on the Unexcitability during Ablation
Date of disclosure of the study information 2017/10/11
Last modified on 2017/10/10

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Basic information
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
Condition atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Department of Cardiology, Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Cardiology, Hirosaki University Graduate School of Medicine
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
2017 Year 10 Month 11 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 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
Other related information

Management information
Registered date
2017 Year 10 Month 10 Day
Last modified on
2017 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033697

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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