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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06236776
Other study ID # 1-2023-0031
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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