UMIN-CTR Clinical Trial

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