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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025570
Receipt No. R000029235
Scientific Title A study on safety and efficacy of atrial fibrillation ablation using ThermoCoolTM SmartTouchTM Surround Flow catheter: comparison with ThermoCool TM SmartTouch TM (thermo cool smart touch) catheter
Date of disclosure of the study information 2017/01/30
Last modified on 2017/01/07

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Basic information
Public title A study on safety and efficacy of atrial fibrillation ablation using ThermoCoolTM SmartTouchTM Surround Flow catheter: comparison with ThermoCool TM SmartTouch TM (thermo cool smart touch) catheter
Acronym Importance of considering the impact of surround flow irrigation to achieve safe and effective contact force-guided circumferential pulmonary vein isolation
Scientific Title A study on safety and efficacy of atrial fibrillation ablation using ThermoCoolTM SmartTouchTM Surround Flow catheter: comparison with ThermoCool TM SmartTouch TM (thermo cool smart touch) catheter
Scientific Title:Acronym Importance of considering the impact of surround flow irrigation to achieve safe and effective contact force-guided circumferential pulmonary vein isolation
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 the safety and effectiveness of the ThermoCool SmartTouch Surround Flow (STSF) catheter with the conventional ThermoCool SmartTouch (ST) catheter. Furthermore, we will investigate electrophysiologically whether contact force, which is an indicator established by ST catheter, can be used in STSF as well.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time (sec) until pacing (rate 120 beats / minute) becomes impossible to capture atrial muscle by radiofrequency ablation
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 ThermoCool SmartTouch
Interventions/Control_2 ThermoCool SmartTouch Surround Flow
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 A) Patients who satisfy atrial fibrillation ablation adaptation criteria in Japan
B) Patients who can perform electrical defibrillation immediately before ablation treatment, return to sinus rhythm and maintain sinus rhythm
C) Patients over 20 years old
D) After receiving sufficient explanation for the participation of this study, patients who gained written consent by the patient's free will with sufficient understanding
Key exclusion criteria A) Patients who do not return to sinus rhythm by electrical defibrillation
B) Patients who repeat recurrence of atrial fibrillation although returning to sinus rhythm by electrical defibrillation
C) Patients with low left ventricular function (left ventricular ejection fraction: 30% or less) or acute heart failure combined
D) Patients undergoing dialysis
E) Patients judged inappropriate as subjects by doctors
F) Patients who are participating in, or are expected to participate in, studies that may affect this study

Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Horiuchi
Organization Hirosaki University Graduate School of Medicine
Division name Department of Advance Management of Cardiac Arrhythmias
Zip code
Address Zaifu-cho 5 Hirosaki 036-8562 JAPAN
TEL 0172-39-5144
Email horiuch@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Natsumi Nigawara
Organization Hirosaki University Graduate School of Medicine
Division name Department of Advance Management of Cardiac Arrhythmias
Zip code
Address Zaifu-cho 5 Hirosaki 036-8562 JAPAN
TEL 0172-39-5144
Homepage URL
Email niga8ra@hirosaki-u.ac.jp

Sponsor
Institute Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Advance Management of Cardiac Arrhythmias
Organization
Division
Category of Funding Organization Self funding
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 01 Month 30 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
2016 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 30 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 01 Month 07 Day
Last modified on
2017 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029235

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2017/07/09 アブレーション研究会演題 Umin中間報告 登録時.docx


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