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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov