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AWARE Registry: Wearable ECG in Structural Heart Interventions

NCT06236776 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-02-01

No results posted yet for this study

Summary

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.

Conditions

  • Atrial Septal Defect
  • Patent Foramen Ovale

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Iksung Cho · Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06236776 on ClinicalTrials.gov