UMIN-CTR Clinical Trial

Basic information
Public title	An analysis on usefulness of monitoring by wristwatch-type sphygmograph in evaluation of recurrence of atrial fibrillation after catheter ablation (CVI ARO 3b study)
Acronym	CVI ARO 3b study
Scientific Title	An analysis on usefulness of monitoring by wristwatch-type sphygmograph in evaluation of recurrence of atrial fibrillation after catheter ablation (CVI ARO 3b study)
Scientific Title:Acronym	CVI ARO 3b study
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the accuracy of wristwatch-type sphygmograph in detection of recurrence of atrial fibrillation after catheter ablation in comparison to 24h ambulatory electrocardiogram, and to evaluate the difference between 72h and 24h monitoring for this purpose.
Basic objectives2	Others
Basic objectives -Others	Evaluation of usefulness of sphygmographic devise
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Recurrence of atrial fibrillation
Key secondary outcomes

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	Patients with atrial fibrillation more than 3 months after catheter ablation in the Cardiovascular Institute, who can visit for the second successive day for 24h ambulatory electrocardiogram
Key exclusion criteria	(1) Outdwellers having the difficulty in performance of 24h ambulatory monitoring (visiting for the second successive day) (2) Metallic allergy
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Otsuka Middle name Last name Takayuki
Organization	The Cardiovascular Institute
Division name	Department of cardiovascular medicine
Zip code	106-0031
Address	3-2-19 Nishiazabu, Minato-Ku, Tokyo. ZIP: 106-0031
TEL	+81-3-3408-2151
Email	otsuka@cvi.or.jp

Public contact
Name of contact person	1st name Matsuda Middle name Last name Kazumi
Organization	Cardiovascular Institute Academic Research Organization (CVI ARO)
Division name	Head office
Zip code	106-0031
Address	3-2-19 Nishiazabu, Minato-Ku, Tokyo
TEL	+81-3-3408-2151
Homepage URL
Email	matsuda@cvi.or.jp

Sponsor
Institute	The Cardiovascular Institute Academic Organization (CVI ARO)
Institute
Department

Funding Source
Organization	Seiko Epson Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Ethical Committee of The Cardiovascular Institute
Address	3-2-19 Nishiazabu, Minato-Ku, Tokyo
Tel	03-3408-2151
Email	matsuda@cvi.or.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	心臓血管研究所付属病院（The Cardiovascular Institute）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 13 Day

Related information
URL releasing protocol	https://www.cvi.or.jp/kenkyujo/cviaro.html
Publication of results	Published

Result
URL related to results and publications	https://www.cvi.or.jp/kenkyujo/cviaro.html
Number of participants that the trial has enrolled	199
Results	Totally, 199 patients undergoing catheter ablation for atrial fibrillation were enrolled. Post procedural arrhythmia (PPA) was detected by holter ECG in 7 patients, while 26 patients were diagnosed as PPA by pulse-wave sensitive wrist-watch (PWSW). Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the detection of PPA with PWSW were 71.4%, 89.1%, 19.2%, 99.8%, respectively.
Results date posted	2020 Year 12 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients undergoing catheter ablation for atrial fibrillation were enrolled.
Participant flow	Data of all participants were assessed.
Adverse events	None.
Outcome measures	Post procedural arrhythmia (PPA) was detected by holter ECG in 7 patients, while 26 patients were diagnosed as PPA by pulse-wave sensitive wrist-watch (PWSW). Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the detection of PPA with PWSW were 71.4%, 89.1%, 19.2%, 99.8%, respectively.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 19 Day
Date of IRB	2016 Year 05 Month 09 Day
Anticipated trial start date	2015 Year 05 Month 15 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	Investigation was completed.

Management information
Registered date	2016 Year 06 Month 13 Day
Last modified on	2020 Year 12 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025937