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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035284
Receipt No. R000040194
Scientific Title Nagano Chuo Hospital Balloon Ablation Study
Date of disclosure of the study information 2018/12/27
Last modified on 2019/05/02

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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
Email 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
Email hdc@healthcoop-nagano.or.jp

Sponsor
Institute Nagano Chuo Hospital
Institute
Department

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
Email a-uehara@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
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 Enrolling by invitation
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
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 17 Day
Last modified on
2019 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040194

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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