AWARE Registry: Wearable ECG in Structural Heart Interventions

Launched by YONSEI UNIVERSITY · Jan 24, 2024

Keywords

ClinConnect Summary

The AWARE Registry study is looking at patients who are having a specific heart procedure called device closure for conditions known as atrial septal defect or patent foramen ovale. These conditions involve holes in the heart that can lead to problems with blood flow. The study will track patients by performing heart ultrasound tests before the procedure, right after, and again at 6, 18, and 30 months later. Participants will also wear a device that monitors their heart's electrical activity for more than three days, either before or right after the procedure.

To be eligible for this study, you need to be at least 19 years old and scheduled for the heart procedure mentioned. You also need to provide written consent to take part in the study. However, if you have certain heart issues like irregular heartbeats or a life expectancy of less than 12 months, you won’t be able to participate. This study aims to gather important information about the effectiveness and safety of these heart procedures, which could help improve care for future patients.

Gender

ALL

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