AWARE Registry: Wearable ECG in Structural Heart Interventions
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorYonsei University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients who had paroxysmal, persistent, or chronic AF
Life expectancy < 12 months
Subject who the investigator deems inappropriate to participate in this study
Trial population
Patients who scheduled to perform percutaneous device closure for atrial septal defect or patent foramen ovale
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Occurrence of atrial fibrillation
Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring
Time frame
Immediate post-operative2
Occurrence of atrial fibrillation
Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring
Time frame
18 month3
Occurrence of atrial fibrillation
Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring
Time frame
30 monthSecondary outcomes
1
All cause-death
Time frame
Immediate post-operative, 18 month , 30 month2
hospitalization for heart failure
hospitalization for heart failure: data from electronic medical record in Yonsei university health system
Time frame
Immediate post-operative, 18 month , 30 month3
new atrial fibrillation
Time frame
Immediate post-operative, 18 month , 30 month4
new atrial tachycardia
Time frame
Immediate post-operative, 18 month , 30 monthSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: