UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035284 |
|---|---|
| Receipt number | R000040194 |
| Scientific Title | Nagano Chuo Hospital Balloon Ablation Study |
| Date of disclosure of the study information | 2018/12/27 |
| Last modified on | 2023/12/08 12:07:50 |
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Basic information
Public title
Nagano Chuo Hospital Balloon Ablation Study
Acronym
Hot and Ice Study
Scientific Title
Nagano Chuo Hospital Balloon Ablation Study
Scientific Title:Acronym
Hot and Ice Study
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of HotBalloon ablation and that of CryoBalloon ablation in patients with paroxysmal atrial fibrillation who undergoing pulmonary vein isolation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Recurrence of any atrial fibrillation or atrial tachycardia by 12 months from ablation
Key secondary outcomes
1.touch-up rate by radio-frequency ablation
2.procedure time (From puncture start to sheath removal)
3.fluoroscopy time
4.complications rate by treatment (Period: 3 months)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
HotBalloon ablation
Sheath:TRESWALTZ
Balloon:SATAKE HotBalloonCatheter(Injection volume:8~20ml)
Interventions/Control_2
CryoBalloon ablation
Sheath:FlexCath Advance Steerable Sheath
Balloon:Arctic Front Advance Cryo Balloon Catheter(Catheter size:28mm)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with paroxysmal atrial fibrillation qualified to catheter ablation according to current standards
Key exclusion criteria
1. unsuitable anatomy of pulmonary vein or left atrium for balloon ablation
2. life expectancy < 12 months
3. difficult to follow up 12 months
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kono |
| Middle name | |
| Last name | Tsunesuke |
Organization
Nagano Chuo Hospital
Division name
Cardiology
Zip code
380-0814
Address
1570 Nishitsurugamachi,Nagano,380-0814,Japan
TEL
026-234-3211
hdc@healthcoop-nagano.or.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamagishi |
Organization
Nagano Chuo Hospital
Division name
Department of Heart Disease Center
Zip code
380-0814
Address
1570 Nishitsurugamachi,Nagano,380-0814,Japan
TEL
026-234-3211
Homepage URL
hdc@healthcoop-nagano.or.jp
Sponsor or person
Institute
Nagano Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagano Chuo Hospital
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
Nagano Chuo Hospital IRB
Address
1570 Nishitsurugamachi,Nagano,380-0814Japan
Tel
026-234-3211
mayumi.nakazawa@healthcoop-nagano.or.jp
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
| 2018 | Year | 12 | Month | 27 | 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
200
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to the time required to write the article, including statistical analysis, the publication of the results has been delayed.
We are currently on the verge of submitting the article and plan to do so soon.
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 17 | Day |
Last modified on
| 2023 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040194
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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