UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020130 |
|---|---|
| Receipt number | 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 12:52:24 |
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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
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
koji3koji3@gmail.com
Sponsor or person
Institute
Division of Arrhythmia and Electrophysiology, Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023255
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