UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025570 |
|---|---|
| Receipt number | 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 11:16:36 |
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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
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
niga8ra@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029235
