AWARE Registry: Wearable ECG in Structural Heart Interventions

Yonsei University

Status: Not yet enrolling

Conditions: Atrial Septal Defect; Patent Foramen Ovale

Study type: Observational

Funder types: Other

Identifiers

NCT06236776

1-2023-0031

Details and patient eligibility

About

This study is a multi-center (Sinchon Severance hospital / Gangnam Severance hospital), prospective cohort observational study to patients who had undergone structural heart intervention including device closure for secundum type atrial septal defect or Patent foramen ovale. Transthoracic echocardiography will be performed before the procedure, immediately after, and at 6, 18, 30 months after the procedure. Wearable ECG monitoring (> 3 days) will be performed before the procedure or immediately after procedure. Demographic, laboratory, hemodynamic data during procedure, and non-invasive imaging dat are obtained.

Enrollment: 150 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult ≥ 19 year-old
• Patients who scheduled to perform percutaneous device closure for atrial septal defect or patent foramen ovale
• Patients provided with the written, informed consent to participate in this study

Exclusion criteria

• Patients who had paroxysmal, persistent, or chronic AF
• Life expectancy < 12 months
• Subject who the investigator deems inappropriate to participate in this study