UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study to evaluate the efficacy of radio frequency ablation and cryoballoon ablation on cardiac autonomic function - a randomized, parallel-group, open study -
Acronym	A clinical study to evaluate the efficacy of radio frequency ablation and cryoballoon ablation on cardiac autonomic function - a randomized, parallel-group, open study -(R and B trial)
Scientific Title	A clinical study to evaluate the efficacy of radio frequency ablation and cryoballoon ablation on cardiac autonomic function - a randomized, parallel-group, open study -
Scientific Title:Acronym	A clinical study to evaluate the efficacy of radio frequency ablation and cryoballoon ablation on cardiac autonomic function - a randomized, parallel-group, open study -(R and B trial)
Region	Japan

Condition
Condition	Atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of cryoballoon ablation on cardiac autonomic function of the paroxysmal atrial fibrillation patients stratified by heart failure, in comparison with RF ablation by MIBG, HRV, NGF-B
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of outcome of MIBG before and after treatment
Key secondary outcomes	1) The change of heart rate variability by Holter electrocardiogram 2)The relation between the change of NGF-B and the index of sympathetic nerve activation 3) The change of hs CRP/PINP/PIIINP 4) The relation between the recurrence within one year and primary outcomes (index predicting recurrence) 5) The relation between the index of sympathetic nerve activation and primary outcomes (including the intraoperative evaluation) 6) Pulmonary vein stenosis on CT

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
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Cryo ablation
Interventions/Control_2	RF 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	1)Patients with paroxysmal atrial fibrillation 2)Patients who received sufficient explanation, understood it and gave written consent based on their free will, before participating in this study
Key exclusion criteria	1)Patients who undergo the treatment other than pulmonary vein isolation, complicated with atrial flutter or paroxysmal supraventricular tachycardia 2)Patients with severe mitral regurgitation or mitral stenosis after pacemaker implantation 3)Hemodialysis patients 4)Patients who are judged inappropriate by the principal investigator
Target sample size	200

Research contact person
Last name of lead principal investigator	1st name Masato Middle name Last name Kawasaki
Organization	Osaka General Medical Center
Division name	Department of Cardiology
Zip code	558-8558
Address	3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL	06-6692-1201
Email	kenkyusien@gh.opho.jp

Public contact
1st name of contact person	1st name Masato Middle name Last name Kawasaki
Organization	Osaka General Medical Center
Division name	Department of Cardiology
Zip code	558-8558
Address	3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL	06-6692-1201
Homepage URL
Email	kenkyusien@gh.opho.jp

Sponsor
Institute	Osaka General Medical Center
Institute
Department

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	Osaka General Medical Center
Address	3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
Tel	06-6692-1201
Email	rinri@gh.opho.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	大阪府立急性期・総合医療センター（大阪府）

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 11 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	2016 Year 01 Month 17 Day
Date of IRB	2016 Year 03 Month 09 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 05 Month 11 Day
Last modified on	2019 Year 05 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025664