Atrial FibrillationNCT04223310
Clinical Usefulness of Virtual Antiarrhythmic Drug Test in Patients With Recurred AF After Catheter Ablation(CUVIA-AF3)
A study testing Virtual AAD TEST group and Empirical AAD group in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
Catheter ablation for atrial fibrillation (AF) is an effective rhythm control method that shows superior rhythm outcome than antiarrhythmic drug (AAD) treatment in drug-resistant AF. However, AF catheter ablation still has a substantial recurrence rate. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Virtual AAD TEST group and Empirical AAD group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jun 2023to Dec 2024
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients with 20~80 years old those recurred AF after catheter ablation
- Patients who are suitable for sinus rhythm conversion and maintenance using AAD medications
- Patients who had no history of serious side effects due to AAD medications before the procedure
Who cannot join
- Permanent AF Patients
- AF associated with significant structural heart disease with severe anomaly or hemodynamic effects
- Patients expected to have serious side effects when using AAD due to sinus node dysfunction
- Severe liver or renal failure
- Patients with past cardiac surgery history
- Patients who are unable to oral medication or have electrolyte abnormalities
Show all 14Show fewer
- Patients with active internal bleeding
- Contraindications for anticoagulant therapy (administered anticoagulant drugs to prevent cerebral infarction) or AAD
- Valvular AF (mitral stenosis> grade 2, mechanical valve, mitral valve repair)
- Severe concomitant illness
- Patients expected to live for less than one year
- Patients with drug or alcoholism
- Those who cannot read the agreement (literacy, foreigners, etc.)
- Patients judged to be inappropriate for participation in clinical trials by other researchers' judgment
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, 120-752
Hui-Nam Pak, M.D., Ph.D., 82-2-2228-8459, hnpak@yuhs.ac
About this study
Catheter ablation for atrial fibrillation (AF) is an effective rhythm control method that shows superior rhythm outcome than antiarrhythmic drug (AAD) treatment in drug-resistant AF. However, AF catheter ablation still has a substantial recurrence rate.
The current AAD use guidelines for AF management focus on the safety of drug use. However, if the AAD efficacy evaluation system using computer modeling reflecting the individual anatomy, electrophysiology, and histological characteristics of patients is practical, it will help to select a more effective AAD type or dose.
Read more
The purpose of this study is to conduct a prospective randomized clinical study on the efficacy and safety of computer modeling for optimal AAD selection in patients with recurrent AF after catheter ablation. The investigator will evaluate the efficacy of AAD simulations by comparing virtual AAD effect guided therapy and empirical AAD use in patients with recurrent AF after AF catheterization.
The investigator will test the virtual AAD effects in the computer simulations integrated by cardiac images and 3D electrophysiological maps obtained during de novo AF ablation. The investigator will compare the effects of the most potent AAD selected by virtual AAD simulation with those of empirical AAD.
Read the detailed description
- Study design
- Prospective randomization (Virtual AAD TEST group vs. Empirical AAD group )
- Target number of subjects: 300 (150 per group)
- Rhythm FU : 2012 ACC/AHA/ESC guidelines (Holter monitoring at the baseline, 2 month, and thereafter every 6 months; ECG if the patient has any symptom)
- Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines
- All complications in each group will be evaluated including the re-hospitalization rate, cardioversion frequency, major cardiovascular event, and mortality rate.
- Progress and rhythm/ECG follow-up
- To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management
- Follow-up at 2 weeks, 2 months, and thereafter every 6-month after medication.
- Rhythm control at 2 months, and thereafter every 6-month follow-up with Holter after medication
- If the patient complains of symptoms, ECG will be performed at any time, and rhythm follow-up will be carried out with a Holter or event recorder.
- Follow-up All the patients will be followed-up at 2 weeks, 2, 6 months, and thereafter every 6 months. If the patient shows any symptom within the clinical study period, patient will visit the outpatient clinic. ECG will be performed at every outpatient visits, and 24-hour Holter or event recording will be performed 2months and every 6 months for 2 years, and every year after 2 years (2012 Heart Rhythm Society/EHRA/European Cardiac Arrhythmia Society Expert Consensus Statement guidelines). If atrial fibrillation or atrial tachycardia lasting more than 30 seconds is observed in 12-lead ECG or Holter, it will be evaluated as recurrence. Recurrence within 3 months after the procedure will be classified as early recurrence, and that after 3 months will be classified as clinical recurrence.
- Conditions
- Atrial Fibrillation
- Being tested
- Virtual AAD TEST group, Empirical AAD group
- Keywords
- Recurred Atrial Fibrillation After AFCA, AF catheter ablation, Virtual antiarrhythmic drug test
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual AAD TEST groupDrug
- Perform virtual AAD test using a voltage map acquired during de novo AF ablation procedure
- Preselect drug with optimal antiarrhythmic effects in the patient.
- Take an AAD selected by virtual AAD simulation in patients who recur AF after catheter resection
- Drug selection should be decided according to the guidelines.
- A follow-up of rhythm follow-up has to be conducted according to the above study design.
Empirical AAD groupDrug
- Perform virtual AAD test using a voltage map acquired during de novo AF ablation procedure
- Selection of AAD based on the experience of the attending physician, independent of the results of the virtual AAD test in patients who recur AF after catheter resection
- Drug selection should be decided according to the guidelines.
- A follow-up of rhythm follow-up has to be conducted according to the above study design.
| Study group | Role | What they receive |
|---|---|---|
| Virtual AAD TEST group | Experimental | 1. Perform virtual AAD test using a voltage map acquired during de novo AF ablation procedure
2. Preselect drug with optimal antiarrhythmic effects in the patient.
3. Take an AAD selected by virtual AAD simulation in patients who recur AF after catheter resection
4. Drug selection should be decided according to the guidelines.
5. A follow-up of rhythm follow-up has to be conducted according to the above study design. Receives: Drug: Virtual AAD TEST group |
| Empirical AAD group | Active comparator | 1. Perform virtual AAD test using a voltage map acquired during de novo AF ablation procedure
2. Selection of AAD based on the experience of the attending physician, independent of the results of the virtual AAD test in patients who recur AF after catheter resection
3. Drug selection should be decided according to the guidelines.
4. A follow-up of rhythm follow-up has to be conducted according to the above study design. Receives: Drug: Empirical AAD group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy evaluation: clinical recurrence rate
Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 year. Based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms
Measured: At 2 months after medication
Efficacy evaluation: clinical recurrence rate
Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 year. Based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms
Measured: At 6months after medication
Efficacy evaluation: clinical recurrence rate
Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 year. Based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms
Measured: At 12 months after medication
Efficacy evaluation: clinical recurrence rate
Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 year. Based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms
Measured: At 18 months after medication
Efficacy evaluation: clinical recurrence rate
Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 year. Based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms
Measured: At 24months after medication
Safety evaluation: Major cardiovascular event rate after medication
Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage
Measured: At 2 months after medication
Safety evaluation: Major cardiovascular event rate after medication
Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage
Measured: At 6 months after mediation
Safety evaluation: Major cardiovascular event rate after medication
Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage
Measured: At 12 months after mediacation
Safety evaluation: Major cardiovascular event rate after medication
Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage
Measured: At 18 months after mediacation
Safety evaluation: Major cardiovascular event rate after medication
Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage
Measured: At 24 months after mediacation
Secondary outcomes (25)
Comparison of cardioversion frequency
comparison of cardioversion fequency after medication (including re-hospitalization for complication by heart failure, embolism and hemorrhage)
Measured: At 2 months after medication
Comparison of cardioversion frequency
comparison of cardioversion fequency after medication (including re-hospitalization for complication by heart failure, embolism and hemorrhage)
Measured: At 6 months after medication
Comparison of cardioversion frequency
comparison of cardioversion fequency after medication (including re-hospitalization for complication by heart failure, embolism and hemorrhage)
Measured: At 12 months after medication
Comparison of cardioversion frequency
comparison of cardioversion fequency after medication (including re-hospitalization for complication by heart failure, embolism and hemorrhage)
Measured: At 18 months after medication
Comparison of cardioversion frequency
comparison of cardioversion fequency after medication (including re-hospitalization for complication by heart failure, embolism and hemorrhage)
Measured: At 24 months after medication
re-ablation(RFCA) fequency
re-ablation(RFCA) fequency after medication.
Measured: At 2 months after medication
re-ablation(RFCA) fequency
re-ablation(RFCA) fequency after medication.
Measured: At 6 months after medication
re-ablation(RFCA) fequency
re-ablation(RFCA) fequency after medication.
Measured: At 12 months after medication
re-ablation(RFCA) fequency
re-ablation(RFCA) fequency after medication.
Measured: At 18 months after medication
re-ablation(RFCA) fequency
re-ablation(RFCA) fequency after medication.
Measured: At 24months after medication
Rate of re-hospitalization
Rate of re-hospitalization after medication
Measured: At 2 months after medication
Rate of re-hospitalization
Rate of re-hospitalization after medication
Measured: At 6 months after medication
Rate of re-hospitalization
Rate of re-hospitalization after medication
Measured: At 12 months after medication
Rate of re-hospitalization
Rate of re-hospitalization after medication
Measured: At 18 months after medication
Rate of re-hospitalization
Rate of re-hospitalization after medication
Measured: At 24 months after medication
Frequency of drug complication
Frequency of drug complication after medication
Measured: At 2 months after medication
Frequency of drug complication
Frequency of drug complication after medication
Measured: At 6 months after medication
Frequency of drug complication
Frequency of drug complication after medication
Measured: At 12 months after medication
Frequency of drug complication
Frequency of drug complication after medication
Measured: At 18 months after medication
Frequency of drug complication
Frequency of drug complication after medication
Measured: At 24 months after medication
Rate of discontinuation of medication
Rate of discontinuation of medication due to complication
Measured: At 2 months after medication
Rate of discontinuation of medication
Rate of discontinuation of medication due to complication
Measured: At 6 months after medication
Rate of discontinuation of medication
Rate of discontinuation of medication due to complication
Measured: At 12 months after medication
Rate of discontinuation of medication
Rate of discontinuation of medication due to complication
Measured: At 18 months after medication
Rate of discontinuation of medication
Rate of discontinuation of medication due to complication
Measured: At 24 months after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start13 Jun 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223310
- Sponsor's protocol ID
- 4-2019-1049
- Status last verified
- Oct 2023
- First submitted
- 20 Dec 2019
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Usefulness of Virtual Antiarrhythmic Drug Test in Patients With Recurred AF After Catheter Ablation(CUVIA-AF3)
- ClinicalTrials.gov ID
- NCT04223310
- Acronym / sponsor ID
- 4-2019-1049
- Conditions
- Atrial Fibrillation
- Keywords
- Recurred Atrial Fibrillation After AFCA, AF catheter ablation, Virtual antiarrhythmic drug test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Jan 2020 (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.
Catheter ablation for atrial fibrillation (AF) is an effective rhythm control method that shows superior rhythm outcome than antiarrhythmic drug (AAD) treatment in drug-resistant AF. However, AF catheter ablation still has a substantial recurrence rate.
The current AAD use guidelines for AF management focus on the safety of drug use. However, if the AAD efficacy evaluation system using computer modeling reflecting the individual anatomy, electrophysiology, and histological characteristics of patients is practical, it will help to select a more effective AAD type or dose.
The purpose of this study is to conduct a prospective randomized clinical study on the efficacy and safety of computer modeling for optimal AAD selection in patients with recurrent AF after catheter ablation. The investigator will evaluate the efficacy of AAD simulations by comparing virtual AAD effect guided therapy and empirical AAD use in patients with recurrent AF after AF catheterization.
The investigator will test the virtual AAD effects in the computer simulations integrated by cardiac images and 3D electrophysiological maps obtained during de novo AF ablation. The investigator will compare the effects of the most potent AAD selected by virtual AAD simulation with those of empirical AAD.
Detailed description
- Study design
- Prospective randomization (Virtual AAD TEST group vs. Empirical AAD group )
- Target number of subjects: 300 (150 per group)
- Rhythm FU : 2012 ACC/AHA/ESC guidelines (Holter monitoring at the baseline, 2 month, and thereafter every 6 months; ECG if the patient has any symptom)
- Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines
- All complications in each group will be evaluated including the re-hospitalization rate, cardioversion frequency, major cardiovascular event, and mortality rate.
- Progress and rhythm/ECG follow-up
- To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management
- Follow-up at 2 weeks, 2 months, and thereafter every 6-month after medication.
- Rhythm control at 2 months, and thereafter every 6-month follow-up with Holter after medication
- If the patient complains of symptoms, ECG will be performed at any time, and rhythm follow-up will be carried out with a Holter or event recorder.
- Follow-up All the patients will be followed-up at 2 weeks, 2, 6 months, and thereafter every 6 months. If the patient shows any symptom within the clinical study period, patient will visit the outpatient clinic. ECG will be performed at every outpatient visits, and 24-hour Holter or event recording will be performed 2months and every 6 months for 2 years, and every year after 2 years (2012 Heart Rhythm Society/EHRA/European Cardiac Arrhythmia Society Expert Consensus Statement guidelines). If atrial fibrillation or atrial tachycardia lasting more than 30 seconds is observed in 12-lead ECG or Holter, it will be evaluated as recurrence. Recurrence within 3 months after the procedure will be classified as early recurrence, and that after 3 months will be classified as clinical recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual AAD TEST group | Experimental | Drug: Virtual AAD TEST group1. Perform virtual AAD test using a voltage map acquired during de novo AF ablation procedure 2. Preselect drug with optimal antiarrhythmic effects in the patient. 3. Take an AAD selected by virtual AAD simulation in patients who recur AF after catheter resection 4. Drug selection should be decided according to the guidelines. 5. A follow-up of rhythm follow-up has to be conducted according to the above study design. |
| Empirical AAD group | Active comparator | Drug: Empirical AAD group1. Perform virtual AAD test using a voltage map acquired during de novo AF ablation procedure 2. Selection of AAD based on the experience of the attending physician, independent of the results of the virtual AAD test in patients who recur AF after catheter resection 3. Drug selection should be decided according to the guidelines. 4. A follow-up of rhythm follow-up has to be conducted according to the above study design. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patients with 20~80 years old those recurred AF after catheter ablation
- Patients who are suitable for sinus rhythm conversion and maintenance using AAD medications
- Patients who had no history of serious side effects due to AAD medications before the procedure
Key exclusion criteria (14 listed)
- Permanent AF Patients
- AF associated with significant structural heart disease with severe anomaly or hemodynamic effects
- Patients expected to have serious side effects when using AAD due to sinus node dysfunction
- Severe liver or renal failure
- Patients with past cardiac surgery history
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 |
|---|---|---|
| Virtual AAD TEST group1. Perform virtual AAD test using a voltage map acquired during de novo AF ablation procedure 2. Preselect drug with optimal antiarrhythmic effects in the patient. 3. Take an AAD selected by virtual AAD simulation in patients who recur AF after catheter resection 4. Drug selection should be decided according to the guidelines. 5. A follow-up of rhythm follow-up has to be conducted according to the above study design. | Drug | Virtual AAD TEST group |
| Empirical AAD group1. Perform virtual AAD test using a voltage map acquired during de novo AF ablation procedure 2. Selection of AAD based on the experience of the attending physician, independent of the results of the virtual AAD test in patients who recur AF after catheter resection 3. Drug selection should be decided according to the guidelines. 4. A follow-up of rhythm follow-up has to be conducted according to the above study design. | Drug | Empirical AAD group |
Primary outcome
Efficacy evaluation: clinical recurrence rate
Time frame: At 2 months after medication
Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 year. Based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms
Efficacy evaluation: clinical recurrence rate
Time frame: At 6months after medication
Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 year. Based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms
Efficacy evaluation: clinical recurrence rate
Time frame: At 12 months after medication
Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 year. Based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms
Efficacy evaluation: clinical recurrence rate
Time frame: At 18 months after medication
Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 year. Based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms
Efficacy evaluation: clinical recurrence rate
Time frame: At 24months after medication
Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 year. Based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms
Safety evaluation: Major cardiovascular event rate after medication
Time frame: At 2 months after medication
Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage
Safety evaluation: Major cardiovascular event rate after medication
Time frame: At 6 months after mediation
Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage
Safety evaluation: Major cardiovascular event rate after medication
Time frame: At 12 months after mediacation
Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage
Safety evaluation: Major cardiovascular event rate after medication
Time frame: At 18 months after mediacation
Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage
Safety evaluation: Major cardiovascular event rate after medication
Time frame: At 24 months after mediacation
Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage
25 secondary outcomes
Comparison of cardioversion frequency
Time frame: At 2 months after medication
Comparison of cardioversion frequency
Time frame: At 6 months after medication
Comparison of cardioversion frequency
Time frame: At 12 months after medication
Comparison of cardioversion frequency
Time frame: At 18 months after medication
Comparison of cardioversion frequency
Time frame: At 24 months after medication
re-ablation(RFCA) fequency
Time frame: At 2 months after medication
re-ablation(RFCA) fequency
Time frame: At 6 months after medication
re-ablation(RFCA) fequency
Time frame: At 12 months after medication
re-ablation(RFCA) fequency
Time frame: At 18 months after medication
re-ablation(RFCA) fequency
Time frame: At 24months after medication
Rate of re-hospitalization
Time frame: At 2 months after medication
Rate of re-hospitalization
Time frame: At 6 months after medication
Rate of re-hospitalization
Time frame: At 12 months after medication
Rate of re-hospitalization
Time frame: At 18 months after medication
Rate of re-hospitalization
Time frame: At 24 months after medication
Frequency of drug complication
Time frame: At 2 months after medication
Frequency of drug complication
Time frame: At 6 months after medication
Frequency of drug complication
Time frame: At 12 months after medication
Frequency of drug complication
Time frame: At 18 months after medication
Frequency of drug complication
Time frame: At 24 months after medication
Rate of discontinuation of medication
Time frame: At 2 months after medication
Rate of discontinuation of medication
Time frame: At 6 months after medication
Rate of discontinuation of medication
Time frame: At 12 months after medication
Rate of discontinuation of medication
Time frame: At 18 months after medication
Rate of discontinuation of medication
Time frame: At 24 months after medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual AAD TEST group and Empirical AAD group in people with Atrial Fibrillation, 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 14 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 13 Oct 2023. 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?
Contact Hui-Nam Park (82-2-2228-8459, hnpak@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy evaluation: clinical recurrence rate (time frame: At 2 months after medication). The study lists 10 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 13 Oct 2023.