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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arrhythmia Assessment in Structural Cardiac Interventions Using Wearable ECG Monitoring: AWARE Registry
- ClinicalTrials.gov ID
- NCT06236776
- Acronym / sponsor ID
- 1-2023-0031
- Conditions
- Atrial Septal Defect, Patent Foramen Ovale
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who scheduled to perform percutaneous device closure for atrial septal defect or patent foramen ovale
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who had paroxysmal, persistent, or chronic AF
- Life expectancy < 12 months
- Subject who the investigator deems inappropriate to participate in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Occurrence of atrial fibrillation
Time frame: 18 month
Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring
Occurrence of atrial fibrillation
Time frame: 30 month
Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring
5 secondary outcomes
All cause-death
Time frame: Immediate post-operative, 18 month , 30 month
hospitalization for heart failure
Time frame: Immediate post-operative, 18 month , 30 month
new atrial fibrillation
Time frame: Immediate post-operative, 18 month , 30 month
new atrial tachycardia
Time frame: Immediate post-operative, 18 month , 30 month
high burden of APC/PVC (>15%)
Time frame: Immediate post-operative, 18 month , 30 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Iksung Cho principal investigator
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Septal Defect and Patent Foramen Ovale, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iksung Cho (82-2-2228-8442, iksungcho@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of atrial fibrillation (time frame: Immediate post-operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.