AWARE Registry: Wearable ECG in Structural Heart Interventions

NCT06236776 | Not Yet Recruiting DMC

• 1 other identifier: 1-2023-0031
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Occurrence of atrial fibrillation

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

  Immediate post-operative

• Occurrence of atrial fibrillation

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

  18 month

• Occurrence of atrial fibrillation

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

  30 month

Secondary Outcomes (5)

• All cause-death

  Immediate post-operative, 18 month , 30 month

• hospitalization for heart failure

  Immediate post-operative, 18 month , 30 month

• new atrial fibrillation

  Immediate post-operative, 18 month , 30 month

• new atrial tachycardia

  Immediate post-operative, 18 month , 30 month

• high burden of APC/PVC (>15%)

  Immediate post-operative, 18 month , 30 month

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who scheduled to perform percutaneous device closure for atrial septal defect or patent foramen ovale

You may qualify if:

• 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

You may not qualify if:

• Patients who had paroxysmal, persistent, or chronic AF
• Life expectancy \< 12 months
• Subject who the investigator deems inappropriate to participate in this study

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Heart Septal Defects, Atrial; Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Iksung Cho

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iksung Cho

CONTACT

82-2-2228-8442; iksungcho@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: February 1, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)