UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041776
Receipt number R000047648
Scientific Title Apple Watch Heart Study KEIO Version
Date of disclosure of the study information 2021/02/01
Last modified on 2023/03/16 13:56:37

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Basic information

Public title

Apple Watch Heart Study KEIO Version
- Atrial fibrillation detection by Apple Watch -

Acronym

Apple Watch Heart Study KEIO Version

Scientific Title

Apple Watch Heart Study KEIO Version

Scientific Title:Acronym

AWHS KEIO

Region

Japan


Condition

Condition

atrial fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analyze and evaluate pulse rates, irregular heartbeat notifications, and ECG recordings measured by the Apple Watch while subjects are at rest or sleeping in relation to atrial fibrillation events documented by 14-day ECG patch devices.

Basic objectives2

Others

Basic objectives -Others

- To construct and evaluate a machine-learning algorithm to identify the optimal timing of pulse/ECG recording for arrhythmia detection.
- To analyze Apple Watch healthcare data in relation to 14-day ECG patch devices, profile data, questionnaire data, and information from medical records, including data from transtelephonic monitors.

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Analysis of the degree of agreement between Apple Watch heart data collected while subjects are at rest or sleeping (pulse rates, irregular heartbeat notifications, and ECG recordings) and 14-day ECG patch data (atrial fibrillation events).

Key secondary outcomes

- Construction and evaluation of a machine-learning algorithm to identify the optimal timing of pulse/ECG recording for arrhythmia detection.
- Evaluation of the relevance of Apple Watch healthcare data and 14-day ECG patch data, profile data, questionnaire data, and information from medical records, including data from transtelephonic monitors.


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

20 years-old <

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

- Is an atrial fibrillation patient receiving treatment at the Department of Cardiology, KEIO University Hospital.
- Aged >= 20 years (no gender restrictions).
- Has access to an iPhone (iOS > 13.0) and Apple Watch (watchOS > 6.0) and can download the research application from the App Store (Japan) (iPhone and Apple Watch can be borrowed).
- Is a Japanese person who can understand Japanese.
- Is capable of understanding the content of this study and giving his/her written consent.

Key exclusion criteria

- Is unable to wear an Apple Watch while sleeping.
- Is unable to operate the research application.
- Is scheduled to be transferred or moved.
- Has been deemed an inappropriate subject by the research supervisor or office.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name Jinzaki

Organization

Keio University School of Medicine

Division name

Department of Radiology

Zip code

160-8582

Address

35 Shinanomachi Shinjuku-ku, Tokyo

TEL

03-5363-3836

Email

jinzaki@rad.med.keio.ac.jp


Public contact

Name of contact person

1st name Takehiro
Middle name
Last name Kimura

Organization

Keio University School of Medicine

Division name

Department of Cardiology

Zip code

160-8582

Address

35 Shinanomachi Shinjuku-ku, Tokyo

TEL

03-5843-6703

Homepage URL


Email

awhs-group@keio.jp


Sponsor or person

Institute

Keio University Hospital

Institute

Department

Personal name



Funding Source

Organization

Biosense Webster Inc.

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University School of Medicine Ethics Committee

Address

35 Shinanomachi Shinjuku-ku, Tokyo

Tel

03-3353-1211 (62014)

Email

med-rinri-jimu@adst.keio.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



Other administrative information

Date of disclosure of the study information

2021 Year 02 Month 01 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

100

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

2020 Year 07 Month 17 Day

Date of IRB

2020 Year 10 Month 29 Day

Anticipated trial start date

2021 Year 01 Month 12 Day

Last follow-up date

2025 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Informed consent will be obtained through a written form and the research application. The participants will be instructed to wear the Apple Watch while at rest and while sleeping, wear a 14-day ECG patch device, answer the questionnaire, and record an ECG twice daily and while experiencing symptoms. The healthcare data and answers will be collected using the research application. The observation period will be 14 consecutive days.


Management information

Registered date

2020 Year 09 Month 13 Day

Last modified on

2023 Year 03 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047648


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name