UMIN-CTR Clinical Trial

Basic information
Public title	Accelerometer assessment of daily physical activity and prognosis after catheter ablation of atrial fibrillation
Acronym	Accelerometer assessment of daily physical activity and prognosis after catheter ablation of atrial fibrillation
Scientific Title	Accelerometer assessment of daily physical activity and prognosis after catheter ablation of atrial fibrillation
Scientific Title:Acronym	Accelerometer assessment of daily physical activity and prognosis after catheter ablation of atrial fibrillation
Region	Japan

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

Objectives
Narrative objectives1	To evaluate daily physical activity and prognosis after catheter ablation of atrial fibrillation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	AF recurrence after the ablation
Key secondary outcomes	Physical activity, degree of AF symptoms

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver Other
Interventions/Control_1	Assessment of daily physical activity using accelerometer and questionnaire from 3-4 weeks before to 6 months after the ablation procedure
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who are scheduled to undergo catheter ablation of AF for the first time in Nagoya university hospital 2) Patients who are able to put on anccelerometer and are followed-up during 6 months after the ablation.
Key exclusion criteria	Patients who do not agree the study inclusion
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Yanagisawa
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Advanced Cardiovascular Therapeutics
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.
TEL	81-52-744-2147
Email	yanagisawa-sato@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Yanagisawa
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Advanced Cardiovascular Therapeutics
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.
TEL	81-52-744-2147
Homepage URL
Email	yanagisawa-sato@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine. Department of Advanced Cardiovascular Therapeutics
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research Suzuken Memorial Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	The Nagoya University Ethics Committee
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi4668550, Japan.
Tel	81-52-744-2423
Email	camcr@med.nagoya-u.ac.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	名古屋大学医学部附属病院(愛知県）

Other administrative information
Date of disclosure of the study information	2017 Year 03 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	20
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	Completed
Date of protocol fixation	2017 Year 01 Month 28 Day
Date of IRB	2017 Year 05 Month 26 Day
Anticipated trial start date	2017 Year 05 Month 26 Day
Last follow-up date	2019 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	2017 Year 02 Month 02 Day
Last modified on	2019 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029665