AWARE Registry: Wearable ECG in Structural Heart Interventions

Arrhythmia Assessment in Structural Cardiac Interventions Using Wearable ECG Monitoring: AWARE Registry

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06236776

Enrollment

150

Registered

2024-02-01

Start date

2024-02-29

Completion date

2028-06-30

Last updated

2024-02-01

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

Conditions

Atrial Septal Defect, Patent Foramen Ovale

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
All cause-death	Immediate post-operative, 18 month , 30 month	—
hospitalization for heart failure	Immediate post-operative, 18 month , 30 month	hospitalization for heart failure: data from electronic medical record in Yonsei university health system
new atrial fibrillation	Immediate post-operative, 18 month , 30 month	—
new atrial tachycardia	Immediate post-operative, 18 month , 30 month	—
high burden of APC/PVC (>15%)	Immediate post-operative, 18 month , 30 month	high burden of APC/PVC ( \>15%): on wearable ECG monitoring

Countries

South Korea

Contacts

Primary ContactIksung Cho

iksungcho@yuhs.ac82-2-2228-8442

Outcome results