UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040339 |
|---|---|
| Receipt number | R000046028 |
| Scientific Title | The prospective randomized comparison study of the effect and safety of left atrial roof linear ablation utilizing the cryoballoon and the radiofrequency catheter ablation in multicenter |
| Date of disclosure of the study information | 2020/05/08 |
| Last modified on | 2021/10/08 07:01:01 |
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Basic information
Public title
The prospective randomized comparison study of the effect and safety of left atrial roof linear ablation utilizing the cryoballoon and the radiofrequency catheter ablation in multicenter
Acronym
The prospective randomized comparison study of the effect and safety of left atrial roof linear ablation utilizing the cryoballoon and the radiofrequency catheter ablation in multicenter
Scientific Title
The prospective randomized comparison study of the effect and safety of left atrial roof linear ablation utilizing the cryoballoon and the radiofrequency catheter ablation in multicenter
Scientific Title:Acronym
The prospective randomized comparison study of the effect and safety of left atrial roof linear ablation utilizing the cryoballoon and the radiofrequency catheter ablation in multicenter
Region
| Japan |
Condition
Condition
non-valvular persistent atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to analyze the effect and safety of left atrial roof linear ablation utilizing the seconed-generation cryoballoon (Arctic Front Advance) and the radiofrequency catheter ablation with the irrigation and contact force sensor from the early to late term. If the linear ablation cannot achieve with assigned energy, using the other energy (crossover) and try to make complete linear blockline.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. the success rate and crossover rate of the each group
Key secondary outcomes
2. the ablation procedure duration, fluoroscopy dose and fluoroscopy duration required to make complete linear blockline in left atrial roof
3. the occurrence rate of cardiac tamponade, systemic embolism, pulmonary vein stenosis, phrenic nerve injury and gastric hypomotility
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Performing the ablation of left atrial roof linear ablation utilizing cryoballoon
Interventions/Control_2
Performing the ablation of left atrial roof linear ablation utilizing radiofrequency catheter 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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the de-novo catheter ablation case with non-valvular atrial fibrillation with sustaining period less than 5 years
Key exclusion criteria
left atrial diameter more than 55mm
persistent atrial fibrillation sustaining more than 5 years
left ventricle ejection fraction less than 30%
severe valvular disease
reversible atrial fibrillation like hyperthyroidism
intra-cardiac thrombosis
frail patient
NYHA 4
myocardial infarction or cardiac surgery within 3 months
severe bleeding
no durability for heparin or direct oral anticoagulant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuteru |
| Middle name | |
| Last name | Yamauchi |
Organization
Japanese Red Cross Yokohama City Bay Hospital
Division name
Department of Cardiology
Zip code
231-8682
Address
3-12-1 Shinyamashita, Naka-ku, Yokohama-city, Kanagawa
TEL
0456286100
yasuteru1020@gmail.com
Public contact
Name of contact person
| 1st name | Tatsuhiko |
| Middle name | |
| Last name | Hirao |
Organization
Japanese Red Cross Yokohama City Bay Hospital
Division name
Department of Cardiology
Zip code
231-8682
Address
3-12-1 Shinyamashita, Naka-ku, Yokohama-city, Kanagawa
TEL
0456286100
Homepage URL
tatsuhiko1984@gmail.com
Sponsor or person
Institute
Japanese Red Cross Yokohama City Bay Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Yokohama City Bay Hospital
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
Japanese Red Cross Yokohama City Bay Hospital
Address
3-12-1 Shinyamashita, Naka-ku, Yokohama-city, Kanagawa
Tel
0456286100
s-furuta.ji@yokohama.jrc.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
| 2020 | Year | 05 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 05 | Month | 08 | Day |
Last modified on
| 2021 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046028
