Diagnostic validation of wearable continuous ECG monitoring patch, ATP-C120, in high risk patients for new-onset atrial fibrillation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005650

Enrollment

320

Registered

2020-12-02

Start date

2020-11-30

Completion date

Unknown

Last updated

2021-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : The attachment type ECG (ATP-C120) is a disposable patch attached to the upper left side of the chest and allows the use of batteries mounted inside the device for up to 11 days. Data

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients who normally need hospital admission or outpatient care with two or more CHA2DS2-VASc scores -Self-written consenting person. Definition of CHA2DS2_VASc core: 1 point [double] for each of the following items is 2 point Constructive heart failure, Hypertension, Age 75 years [doubled] Diabets, preor stroke or TIA [doubled] Vascular daise, Age 65-74 years, Sex category [female]

Exclusion criteria

Exclusion criteria: - Patients who have already been diagnosed with atrial fibrillation - Patients with an artificial heartbeat or implantable defibrillator - Patients with a history of skin diseases or adverse events related to previous ECG patches

Design outcomes

Primary

Measure	Time frame
Rate atrial fibrillation is diagnosed on the attached ECG	—

Secondary

Measure	Time frame
incidence and combination of death, stroke, myocardial infarction or systemic embolism	—

Countries

Korea, Republic of

Contacts

Public ContactGahyun Lee

Seoul National University Bundang Hospital

Outcome results