UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022723 |
|---|---|
| Receipt number | R000025937 |
| 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) |
| Date of disclosure of the study information | 2016/06/13 |
| Last modified on | 2020/12/16 10:41:18 |
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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
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
matsuda@cvi.or.jp
Sponsor or person
Institute
The Cardiovascular Institute Academic Organization (CVI ARO)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025937
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