AWARE Registry: Wearable ECG in Structural Heart Interventions

N/ANot Yet RecruitingNCT06236776

Yonsei University150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Atrial Septal Defect Patent Foramen Ovale

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

Occurrence of atrial fibrillation

Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring

Time frame: Immediate post-operative

Occurrence of atrial fibrillation

Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring

Time frame: 18 month

Occurrence of atrial fibrillation

Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring

Time frame: 30 month