NCT06236776|Not Yet RecruitingDMC
AWARE Registry: Wearable ECG in Structural Heart Interventions
Arrhythmia Assessment in Structural Cardiac Interventions Using Wearable ECG Monitoring: AWARE Registry
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Arrhythmia Assessment in Structural Cardiac Interventions Using Wearable ECG Monitoring: AWARE Registry
Sponsor study identifier
observational
150
1 country
1
Study Start
February 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 10, 2023
Actual (reported)February 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 1, 2024
Actual (reported)June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Occurrence of atrial fibrillation
Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring
Immediate post-operative
Occurrence of atrial fibrillation
Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring
18 month
Occurrence of atrial fibrillation
Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring
30 month
All cause-death
Immediate post-operative, 18 month , 30 month
hospitalization for heart failure
Immediate post-operative, 18 month , 30 month
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
Patients who scheduled to perform percutaneous device closure for atrial septal defect or patent foramen ovale
Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine
Seoul, 03722, South Korea
Iksung Cho
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
First Submitted
November 10, 2023
First Posted
February 1, 2024
Study Start
February 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2028
EstimatedCerebral Microembolization Associated With PFO Closure
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 1, 2024
Record last verified: 2024-01
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Source: ClinicalTrials.gov.
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