Atrial Septal DefectNCT06236776
AWARE Registry: Wearable ECG in Structural Heart Interventions
An observational study of Atrial Septal Defect and Patent Foramen Ovale, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Septal Defect, Patent Foramen Ovale
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2024to Jun 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who scheduled to perform percutaneous device closure for atrial septal defect or patent foramen ovale
Who may be able to join
- 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
Who cannot join
- Patients who had paroxysmal, persistent, or chronic AF
- Life expectancy < 12 months
- Subject who the investigator deems inappropriate to participate in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine
Seoul, 03722
About this study
Official title: Arrhythmia Assessment in Structural Cardiac Interventions Using Wearable ECG Monitoring: AWARE Registry
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
- Medical subject headings
- Heart Septal Defects, Atrial, Foramen Ovale, Patent
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of atrial fibrillation
Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring
Measured: Immediate post-operative
Occurrence of atrial fibrillation
Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring
Measured: 18 month
Occurrence of atrial fibrillation
Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring
Measured: 30 month
Secondary outcomes (5)
All cause-death
Measured: Immediate post-operative, 18 month , 30 month
hospitalization for heart failure
hospitalization for heart failure: data from electronic medical record in Yonsei university health system
Measured: Immediate post-operative, 18 month , 30 month
new atrial fibrillation
Measured: Immediate post-operative, 18 month , 30 month
new atrial tachycardia
Measured: Immediate post-operative, 18 month , 30 month
high burden of APC/PVC (>15%)
high burden of APC/PVC ( >15%): on wearable ECG monitoring
Measured: Immediate post-operative, 18 month , 30 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Septal DefectStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iksung Cho, Principal investigator, Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236776
- Sponsor's protocol ID
- 1-2023-0031
- Status last verified
- Jan 2024
- First submitted
- 10 Nov 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No