AWARE Registry: Wearable ECG in Structural Heart Interventions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atrial Septal Defect, Patent Foramen Ovale. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Arrhythmia Assessment in Structural Cardiac Interventions Using Wearable ECG Monitoring: AWARE Registry
Overview
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.
Primary outcome measures
- Occurrence of atrial fibrillation [Time frame: Immediate post-operative]
- Occurrence of atrial fibrillation [Time frame: 18 month]
- Occurrence of atrial fibrillation [Time frame: 30 month]
Secondary outcome measures (5)
- All cause-death [Time frame: Immediate post-operative, 18 month , 30 month]
- hospitalization for heart failure [Time frame: Immediate post-operative, 18 month , 30 month]
- new atrial fibrillation [Time frame: Immediate post-operative, 18 month , 30 month]
- new atrial tachycardia [Time frame: Immediate post-operative, 18 month , 30 month]
- high burden of APC/PVC (>15%) [Time frame: Immediate post-operative, 18 month , 30 month]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Division of Cardiology, Yonsei University Health System, Yonsei University College of Medi — Seoul
Identifiers
NCT: NCT06236776 · 1-2023-0031