UMIN-CTR Clinical Trial

Basic information
Public title	The Evaluation of Efficacy and Safety of Radiofrequency Ablation and Cryoballoon Ablation in Patients with Atrial Fibrillation and Left Ventricular Dysfunction, Randomized Singlecenter Clinical Trial
Acronym	RF and Cryo Ablation of AF in Patients with LV dysfunction
Scientific Title	The Evaluation of Efficacy and Safety of Radiofrequency Ablation and Cryoballoon Ablation in Patients with Atrial Fibrillation and Left Ventricular Dysfunction, Randomized Singlecenter Clinical Trial
Scientific Title:Acronym	RF and Cryo Ablation of AF in Patients with LV dysfunction
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of RF ablation and cryoablation of AF in patients with LV dysfunction
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. recurrence rate of atrial tachyarrhythmia 1 year after ablation 2. composite of all-cause mortality or worsening of heart failure requiring unplanned hospitalization
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	cryoballoon 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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Atrial fibrillation 2. Reduced LV contraction
Key exclusion criteria	1. Prior history of catheter ablation and/or surgery for atrial fibrillation 2. Normal LV contraction 3. Left atrial dimension more than 55 mm 4. Common pulmonary vein 5. Pregnant
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Kengo Middle name Last name Kusano
Organization	National Cerebral and Cardiovascular Center
Division name	Division of Arrhythmia and Electrophysiology, Department of Cardiovascular Medicine
Zip code	564-8565
Address	6-1, Kishibeshimmachi, Suita, Osaka
TEL	06-6170-1070
Email	kusanokengo@gmail.com

Public contact
Name of contact person	1st name Koji Middle name Last name Miyamoto
Organization	National Cerebral and Cardiovascular Center
Division name	Division of Arrhythmia and Electrophysiology, Department of Cardiovascular Medicine
Zip code	564-8565
Address	6-1, Kishibeshimmachi, Suita, Osaka
TEL	06-6170-1070
Homepage URL
Email	koji3koji3@gmail.com

Sponsor
Institute	Division of Arrhythmia and Electrophysiology, Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization	Basic Research Program of National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB, National Cerebral and Cardiovascular Center
Address	6-1, Kishibeshinmachi, Suita, Osaka
Tel	06-6170-1070
Email	rec-office-ac@ncvc.go.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	2018 Year 05 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	2018 Year 04 Month 25 Day
Date of IRB	2018 Year 04 Month 25 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 30 Day
Last modified on	2022 Year 11 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036985