Atrial Fibrillation (AF)AMPEANCT06752733
Cardiac Stunning After Electrical Cardioversion
An observational study of Atrial Fibrillation (AF), run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
The goal of this observational study is to evaluate cardiac stunning and electrocardiographic parameters through transthoracic echocardiography and 24 hours ECG conducted immediately following electrical cardioversion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- electrical cardioversion
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Feb 2024to 31 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Korea University College of Medicine, Guro Hospital
Who may be able to join
- Patients with atrial fibrillation
- Patients with persistent or symptomatic atrial fibrillation who are candidates for electrical cardioversion
- Patients eligible for anticoagulation therapy for thromboembolism prevention before and after the procedure
- Patients who can understand and provide written informed consent
Who cannot join
- Patients under 18 years of age or over 80 years of age
- Patients who do not consent to participate in the study
- Patients with severe coronary artery stenosis
- Patients with severe hepatic dysfunction
- Patients with severe renal dysfunction
- Patients with severe valvular heart disease
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- Patients with a high risk of severe bleeding
- Patients with a history of atrial fibrillation-related catheter ablation or cardiac surgery
- Patients with an expected life expectancy of less than 1 year
- Potentially pregnant individuals
- Patients deemed unsuitable for the study by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between Myocardial Stunning and Long-term Prognosis After Electrical Cardioversion in Patients with Atrial Fibrillation
The goal of this observational study is to evaluate cardiac stunning and electrocardiographic parameters through transthoracic echocardiography and 24 hours ECG conducted immediately following electrical cardioversion. The main question it aims to answer is:
Do echocardiographic and electrocardiographic parameters relating to cardiac stunning predict atrial fibrillation (AF) recurrence rates after electrical cardioversion?
Participants will undergo echocardiography and a 24-hour Holter monitoring immediately after electrical cardioversion.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- electrical cardioversion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical cardioversionProcedure or surgery
synchronized electrical shocks to restore normal sinus rhythm in patients with atrial fibrillation, performed under sedation
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation | A group of patients with atrial fibrillation refractory to pharmacological treatment who are candidates for electrical cardioversion Receives: Procedure: electrical cardioversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence of atrial arrhythmia
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start20 Feb 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roh Seung Young, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752733
- Sponsor's protocol ID
- 2020GR0213
- Acronym
- AMPEA
- Status last verified
- Jan 2024
- First submitted
- 23 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Myocardial Stunning and Long-term Prognosis After Electrical Cardioversion in Patients with Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06752733
- Acronym / sponsor ID
- AMPEA / 2020GR0213
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 31 Dec 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.
The goal of this observational study is to evaluate cardiac stunning and electrocardiographic parameters through transthoracic echocardiography and 24 hours ECG conducted immediately following electrical cardioversion. The main question it aims to answer is:
Do echocardiographic and electrocardiographic parameters relating to cardiac stunning predict atrial fibrillation (AF) recurrence rates after electrical cardioversion?
Participants will undergo echocardiography and a 24-hour Holter monitoring immediately after electrical cardioversion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation | – | Procedure: electrical cardioversionA group of patients with atrial fibrillation refractory to pharmacological treatment who are candidates for electrical cardioversion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Korea University College of Medicine, Guro Hospital
Key inclusion criteria (4 listed)
- Patients with atrial fibrillation
- Patients with persistent or symptomatic atrial fibrillation who are candidates for electrical cardioversion
- Patients eligible for anticoagulation therapy for thromboembolism prevention before and after the procedure
- Patients who can understand and provide written informed consent
Key exclusion criteria (11 listed)
- Patients under 18 years of age or over 80 years of age
- Patients who do not consent to participate in the study
- Patients with severe coronary artery stenosis
- Patients with severe hepatic dysfunction
- Patients with severe renal dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrical cardioversionsynchronized electrical shocks to restore normal sinus rhythm in patients with atrial fibrillation, performed under sedation | Procedure or surgery | Atrial fibrillation |
Primary outcome
The recurrence of atrial arrhythmia
Time frame: From enrollment to the end of treatment at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Fibrillation (AF), run by Korea University Guro Hospital 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 31 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recurrence of atrial arrhythmia (time frame: From enrollment to the end of treatment at 12 months). 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 31 Dec 2024.