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NCT Number: NCT06236776

AWARE Registry: Wearable ECG in Structural Heart Interventions

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.

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Key information

Conditions

Atrial Septal Defect Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foramen Ovale, Patent Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Patent Foramen Ovale

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Occurrence of atrial fibrillation

    Time frame: Immediate post-operative

    Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring

  2. Occurrence of atrial fibrillation

    Time frame: 18 month

    Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring

  3. Occurrence of atrial fibrillation

    Time frame: 30 month

    Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring

Secondary outcomes

  1. All cause-death

    Time frame: Immediate post-operative, 18 month , 30 month

  2. hospitalization for heart failure

    Time frame: Immediate post-operative, 18 month , 30 month

    hospitalization for heart failure: data from electronic medical record in Yonsei university health system

  3. new atrial fibrillation

    Time frame: Immediate post-operative, 18 month , 30 month

  4. new atrial tachycardia

    Time frame: Immediate post-operative, 18 month , 30 month

  5. high burden of APC/PVC (>15%)

    Time frame: Immediate post-operative, 18 month , 30 month

    high burden of APC/PVC ( >15%): on wearable ECG monitoring

Study contacts

Contact information is provided by the study sponsor or research team.

Iksung Cho

CONTACT

[email protected]

82-2-2228-8442

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Arrhythmia Assessment in Structural Cardiac Interventions Using Wearable ECG Monitoring: AWARE Registry

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 1, 2024
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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