UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000020130
Receipt No. R000023255
Scientific Title The Evaluation of Efficacy and Safety of Additional Freezing of Cryoballoon Ablation in Patients with Paroxysmal Atrial Fibrillation, Randomized Multicenter Clinical Trial
Date of disclosure of the study information 2015/12/10
Last modified on 2019/12/12 (Ver. 13)

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Basic information
Public title The Evaluation of Efficacy and Safety of Additional Freezing of Cryoballoon Ablation in Patients with Paroxysmal Atrial Fibrillation, Randomized Multicenter Clinical Trial
Acronym Additional Freezing of Cryoballoon Ablation
Scientific Title The Evaluation of Efficacy and Safety of Additional Freezing of Cryoballoon Ablation in Patients with Paroxysmal Atrial Fibrillation, Randomized Multicenter Clinical Trial
Scientific Title:Acronym Additional Freezing of Cryoballoon Ablation
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of additional freezing of cryoballoon ablation in patients with paroxysmal atrial fibrillation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes recurrence rate of atrial tachyarrhythmia 1 year after ablation
evaluation of ablation lesion using MRI
Key secondary outcomes complication of cyroballoon ablation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 additional freezing of cryoballoon ablation
Interventions/Control_2 no additional freezing of cryoballoon 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 Paroxysmal atrial fibrillation receiving cryoballoon ablation
Key exclusion criteria pregnant
allergy to contrast agent
Target sample size 110

Research contact person
Name of lead principal investigator
1st name Kengo
Middle name
Last name Kusano
Organization National Cerebral and Cardiovascular Center
Division name Division of Arrhythmia and Electrophysiology, Department of Cardiovascular Medicine
Zip code 564-8565
Address 5-7-1 Fujishiro-dai, Suita, Osaka
TEL 06-6833-5012
Email kusanokengo@hotmail.com

Public contact
Name of contact person
1st name Koji
Middle name
Last name Miyamoto
Organization National Cerebral and Cardiovascular Center
Division name Division of Arrhythmia and Electrophysiology, Department of Cardiovascular Medicine
Zip code 564-8565
Address 5-7-1 Fujishiro-dai, Suita, Osaka
TEL 06-6833-5012
Homepage URL
Email koji3koji3@gmail.com

Sponsor
Institute Division of Arrhythmia and Electrophysiology, Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization The present study was supported by Intramural Research Fund (25-4-7) for Cardiovascular Diseases of National Cerebral and Cardiovascular Center
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 IRB, National Cerebral and Cardiovascular Center
Address 6-1, Kishibeshinmachi, Suita, Osaka
Tel 06-6170-1070
Email rec-office-ac@ncvc.go.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
2015 Year 12 Month 10 Day

Related information
URL releasing protocol na
Publication of results Published

Result
URL related to results and publications na
Number of participants that the trial has enrolled 110
Results 
No significant differences in safety and efficacy between groups
Results date posted
2019 Year 12 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
PAF
Participant flow 
Follow up after cryoablation
Adverse events 
Complications occurred in 10 patients (18%) in the AD group and 8 (15%) in the non-AD group (P=0.61; Table 3). Two patients died during follow up period.
Outcome measures 
Recurrence rate of atrial tachyarrhythmia
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 05 Month 29 Day
Date of IRB
2015 Year 04 Month 06 Day
Anticipated trial start date
2015 Year 04 Month 06 Day
Last follow-up date
2018 Year 10 Month 20 Day
Date of closure to data entry
2018 Year 10 Month 20 Day
Date trial data considered complete
2018 Year 10 Month 20 Day
Date analysis concluded
2018 Year 10 Month 20 Day

Other
Other related information none

Management information
Registered date
2015 Year 12 Month 09 Day
Last modified on
2019 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023255