AWARE Registry: Wearable ECG in Structural Heart Interventions

Patent Foramen Ovale Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06236776
• Other study ID #: 1-2023-0031
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: June 2028

Study information

• Verified date: January 2024
• Source: Yonsei University
• Contact: Iksung Cho
• Phone: 82-2-2228-8442
• Email: iksungcho[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Septal Defect
• Foramen Ovale, Patent
• Heart Septal Defects, Atrial
• Patent Foramen Ovale

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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