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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040339
Receipt No. 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 2020/05/08

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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
Email 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
Email tatsuhiko1984@gmail.com

Sponsor
Institute Japanese Red Cross Yokohama City Bay Hospital
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 08 Day
Date of IRB
2019 Year 11 Month 22 Day
Anticipated trial start date
2020 Year 05 Month 20 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
2020 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046028

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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