UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of left atrial size on isolation area in the acute phase of pulmonary vein isolation using 28mm cryoballoon
Title of the study (Brief title)	LA size in cryoballoon ablation
Region	Japan

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

Objectives
Narrative objectives1	This study evaluated the impact of the LA size on ISA in the PV antrum after PVI and compared ISA created using second-generation CB ablation and CF-guided RF ablation in the acute phase.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	We evaluated ISA after PVI using 3D-Merge computed tomography images and high-resolution electroanatomical mapping.
Key secondary outcomes	Recurrence rate of atrial fibrillation after ablation

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Symptomatic, drug-refractory paroxysmal AF who were referred to Toyama Prefectural Central Hospital and National Hospital Organization, Kanazawa Medical Center in Japan between February 2017 and August 2017 for their first ablation procedure.
Key exclusion criteria	We exclude patients who received catheter ablation without anatomocai CT merge
Target sample size	80

Research contact person
Name of lead principal investigator	Akio Chikata
Organization	Toyama Prefectural Central Hospital
Division name	Division of Cardiology, Department of Internal Medicine
Address	2-2-78 Nishi-nagae, Toyama
TEL	076-424-1531
Email	akio.chikata@gmail.com

Public contact
Name of contact person	Akio Chikata
Organization	Toyama Prefectural Central Hospital
Division name	Division of Cardiology, Department of Internal Medicine
Address	2-2-78 Nishi-nagae, Toyama
TEL	076-424-1531
Homepage URL
Email	akio.chikata@gmail.com

Sponsor
Institute	Toyama Prefectural Central Hospital
Institute
Department

Funding Source
Organization	Toyama Prefectural Central Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 15 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Using a 3D electroanatomical mapping system, this study evaluated the impact of the LA size on ISA in the PV antrum after PVI and compared ISA created using second-generation CB ablation and CF-guided RF ablation in the acute phase.

Management information
Registered date	2018 Year 02 Month 18 Day
Last modified on	2018 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035798