Photoplethysmography (PPG) Algorithm With Smartwatch in E... | NCT06686940

Studies
Photoplethysmography (PPG) Algorithm With Smartwatch in Evaluation of Atrial Fibrillation Burden

NCT06686940

Sponsor

Beijing Anzhen Hospital

Status

Not yet recruiting

Last Update Posted

Nov 13, 2024Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Atrial Fibrillation (AF)

Interventions

intervention group

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
KS2024100	Other Identifier	Chengdu Xinjikang Technology Co., Ltd

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 30, 2024Estimated

Primary Completion Date

Dec 30, 2034Estimated

Completion Date

Dec 30, 2034Estimated

First Submitted Date

Nov 12, 2024

First Submission Date that Met QC Criteria

Nov 12, 2024

First Posted Date

Nov 13, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2024

Last Update Posted Date

Nov 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the monitoring effect of a smart electrocardiogram watch based on the PPG algorithm on atrial fibrillation burden.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intervention group	Device	The monitoring effect of a smart electrocardiogram watch based on the PPG algorithm on atrial fibrillation burden.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary outcome	all-cause death, cardiovascular death, myocardial infarction, heart failure, stroke, peripheral vascular disease, recurrence of atrial fibrillation diagnosed by electrocardiogram, palpitations symptoms	December 30, 2024 to Decemberr 30, 2034

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Atrial fibrillation patients diagnosed by electrocardiogram
Willing to use long-range electrocardiogram monitoring equipment

Exclusion Criteria:

1.Patients who are allergic to electronic devices or unable to wear watches

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients diagnosed with atrial fibrillation who meet age and health criteria can use electrocardiographic watches for long-term monitoring.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Song Zuo, M.D	Contact	1880142775		song_zuo@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Anzhen Hospital		Beijing	Beijing Municipality	100000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided