UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Catheter ablation on muscle sympathetic nerve activity in patient with atrial fibrillation
Acronym	AFSNA
Scientific Title	Effect of Catheter ablation on muscle sympathetic nerve activity in patient with atrial fibrillation
Scientific Title:Acronym	AFMSNA
Region	Japan

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

Objectives
Narrative objectives1	to investigate whether AF ablation affect muscle sympathetic nerve activity (MSNA).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	reduction in MSNA
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Catheter ablation
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	AF Patients who undergo CA
Key exclusion criteria	1) moderate to severe valvular heart disease 2)Obesity (BMI>30kg/m2) 3)poor controlled DM (HbA1c>10) 4)Sever Neuropathy
Target sample size	40

Research contact person
Name of lead principal investigator	1st name HISAYOSHI Middle name Last name MURAI
Organization	Kanazawa University
Division name	Cardiology
Zip code	9200946
Address	Takaramachi 13-1 Kanazawa
TEL	0762652000
Email	sakurasoma1209@yahoo.co.jp

Public contact
Name of contact person	1st name HISAYOSHI Middle name Last name MURAI
Organization	Kanazawa university
Division name	cardiology
Zip code	920-8641
Address	Takaramachi 13-1 Kanazawa
TEL	0762652000
Homepage URL
Email	sakurasoma1209@yahoo.co.jp

Sponsor
Institute	Kanazawa university
Institute
Department

Funding Source
Organization	Health insurance
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	Kanazawa University hospital
Address	Takaramachi 13-1
Tel	0762652238
Email	sakurasoma1209@yahoo.co.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	2019 Year 06 Month 12 Day

Related information
URL releasing protocol
Publication of results	Partially published

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 06 Month 01 Day
Date of IRB	2016 Year 10 Month 01 Day
Anticipated trial start date	2019 Year 06 Month 01 Day
Last follow-up date	2022 Year 06 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	2019 Year 06 Month 12 Day
Last modified on	2021 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042194