UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052500 |
|---|---|
| Receipt number | R000059912 |
| Scientific Title | Characteristics of two different cryoballoon systems for treatment of paroxysmal atrial fibrillation : Part 2 (CONTRAST-CRYO 2) |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/12/31 21:48:02 |
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Basic information
Public title
Characteristics of two different cryoballoon systems for treatment of paroxysmal atrial fibrillation : Part 2 (CONTRAST-CRYO 2)
Acronym
CONTRAST-CRYO 2 study
Scientific Title
Characteristics of two different cryoballoon systems for treatment of paroxysmal atrial fibrillation : Part 2 (CONTRAST-CRYO 2)
Scientific Title:Acronym
CONTRAST-CRYO 2 study
Region
| Japan |
Condition
Condition
Paroxysmal atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the difference of two cryoballoon systems in catheter ablation for paroxysmal atrial fibrillation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of right phrenic nerve injury during the procedure
Key secondary outcomes
Freedom from any documented atrial tachyarrhythmias during 12 months follow-up after a single ablation procedure beyond 3 months of blanking period
Freedom from any documented atrial fibrillation (AF) episodes
Procedural duration, fluoroscopy time, dose of contrast
Balloon temperature, proportion of veins with PV signals visible before cryoablation, and time-to-isolation of each pulmonary vein
Total number of applications and total freeze duration of each pulmonary vein
Esophageal temperature during freezing
The incidence and location of non-PV arrhythmia foci
Isolation area by cryoballoon ablation
Freedom from repeat ablation procedure
Freedom from direct current cardioversions for recurrent arrhythmias
Prevalence of Peri-procedural complications
Prevalence of pulmonary vein stenosis
Prevalence of air embolism
The impact of operators' experience
Pulmonary vein isolation durability and the location of conduction resumption during second procedure
Freedom from any documented atrial tachyarrhythmias after repeat ablation procedure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Ablation using the Arctic Front Cryoballoon (Medtronic)
Interventions/Control_2
Ablation using the Polarx FIT Cryoballoon (Boston Scientific)
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 initial ablation for paroxysmal atrial fibrillation
At least 1 episode of paroxysmal AF have been documented within last 1 y of enrollment
Key exclusion criteria
Patients who underwent prior cardiac surgery
Patients with AF secondary to a reversible cause
Patients with contraindications to systemic anticoagulation
Patients who are pregnant
Patients who are not considered to be suitable candidates by the attending physician
Target sample size
214
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Sasano |
Organization
Tokyo Medical and Dental University
Division name
Department of cardiovascular medicine
Zip code
113-8519
Address
1-5-45, Bunkyo-ku, Tokyo
TEL
03-5803-5205
sasano.cvm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Miyazaki |
Organization
Tokyo Medical and Dental University
Division name
Department of cardiovascular medicine
Zip code
113-8519
Address
1-5-45, Bunkyo-ku, Tokyo
TEL
0358035205
Homepage URL
mshicvm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
None
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
Tokyo Medical and Dental University IRB
Address
1-5-45, Bunkyo-ku, Tokyo
Tel
03-5803-5096
syomu1.adm@tmd.ac.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
群馬県立心臓血管センター(群馬県) 、神戸市立医療センター中央市民病院(兵庫県)、さいたま赤十字病院(埼玉県)、榊原記念病院(東京都)、湘南鎌倉総合病院(神奈川県)、東京医科歯科大学病院(東京都)、名古屋ハートセンター(愛知県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 01 | 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
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 14 | Day |
Last modified on
| 2023 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059912
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