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AWARE Registry: Wearable ECG in Structural Heart Interventions

Launched by YONSEI UNIVERSITY · Jan 24, 2024

Trial Information

Current as of July 03, 2025

Not yet recruiting

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

About Yonsei University

Yonsei University, a prestigious institution located in South Korea, is renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, Yonsei University leverages its extensive expertise and innovative approaches in various fields of medicine to conduct rigorous clinical trials aimed at improving patient outcomes and advancing healthcare solutions. The university's robust infrastructure, multidisciplinary collaboration, and adherence to ethical standards ensure the integrity and reliability of its research initiatives, making it a key player in the global clinical research landscape.

Locations

Seoul, , Korea, Republic Of

Patients applied

0 patients applied

Trial Officials

Iksung Cho

Principal Investigator

Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported