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Hativ® ELectrocardiogram monitoring on Patients with Sinus rhythm(HELP-S trial)

Hativ® ELectrocardiogram monitoring on Patients with Sinus rhythm(HELP-S trial)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009304
Enrollment
600
Registered
2024-04-05
Start date
2024-05-09
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

None listed

Interventions

None listed

Sponsors

Hallym University Medical Center-Dongtan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults with smartphones aged 19 years or older 2) Patients who exhibit sinus rhythm and are at a high risk for atrial fibrillation (determined by a risk factor score of =4 on C2HEST or HATCH) 3) The participant signed an informed consent for this study and is capable of comprehending and following the training and instructions

Exclusion criteria

Exclusion criteria: 1) Patients with a physical disability who are unable to use a portable electrocardiogram (Hativ P30®) 2) Patients with an intracardiac device such as a pacemaker, ICD, CRT, VAD, etc. 3) Subjects who are unable to read the consent form (illiterate, foreigners, etc.) 4) Patients deemed unsuitable for participation in the study by the investigator. 5) Patients with previously diagnosed or treated atrial fibrillation 6) Patients taking amiodarone

Design outcomes

Primary

MeasureTime frame
Diagnostic yield

Secondary

MeasureTime frame
Therapeutic intervention status;Cost-effectiveness;Satisfaction;Usability

Countries

Korea, Republic of

Contacts

Public ContactSeong Woo Han

Hallym University Medical Center-Dongtan

hansw29@hallym.or.kr+82-2-1522-2500

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026