Atrial FibrillationNCT04942171
EMOTIon and COgNitive Function After Atrial Fibrillation Catheter Ablation vs. Medical Therapy(EMOTICON Trial)
A study testing Atrial fibrillation catheter ablation group and Medical therapy group in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
"Atrial fibrillation (AF) is an arrhythmic disease that increases especially in the elderly, increasing the risk of ischemic stroke by 5 times and is a major cause of dementia and cognitive impairment. 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?
- Atrial fibrillation catheter ablation group and Medical therapy group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2021to 23 Feb 2026
- 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
- Patients aged between 20 and 80 years of age who have appropriate indication for catheter ablation for AF
- AF patients with left atrium diameter <55 mm
- Antiarrhythmic drug-resistant AF
- Anticoagulation eligible patients
Who cannot join
- AF associated with severe cardiac malformation or structural heart disease
- Patients undergoing treatment for cognitive disorders, emotional disorders, and anxiety disorders
- Patients with severe renal dysfunction or difficulty in CT imaging using contrast media
- Patients with a previous history of AF ablation or other open heart surgery
- Patients with active internal bleeding
- Anticoagulant therapy not eligible patients
Show all 12Show fewer
- Valvular AF (mitral valve stenosis>grade 2, mechanical valve, mitral valve reconstruction)
- Significant comorbidities
- Patients with an expected survival period of less than 1 year
- Drug or alcohol addiction patients
- Among eligible persons, those who cannot read the consent form (illiteracy, foreigners, etc.)
- Patients judged to be unsuitable for participation in clinical research based on the judgment of other researchers
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
Hui-Nam Pak, 82-2-2228-8459, hnpak@yuhs.ac
About this study
Official title: EMOTIon and COgNitive Function After Atrial Fibrillation Catheter Ablation vs. Medical Therapy; Randomized Clinical Trial (EMOTICON Trial)
"Atrial fibrillation (AF) is an arrhythmic disease that increases especially in the elderly, increasing the risk of ischemic stroke by 5 times and is a major cause of dementia and cognitive impairment.
Cognitive dysfunction accompanying AF occurs regardless of the presence or absence of stroke, and AF itself is known to affect cognitive function.
Read more
However, since cognitive dysfunction is also affected by various accompanying chronic diseases, whether the cognitive dysfunction accompanying AF is due to subclinical ischemic stroke, cerebral hypoperfusion due to reduced cardiac output, inflammatory reaction or platelet dysfunction are unclear.
Recently, this research team reported an improvement in cognitive function with active sinus rhythm therapy such as AF catheter ablation. Nevertheless, it has not yet been proven whether such active and invasive AF treatment affects the improvement of cognitive function or depression by a randomized clinical trial.
In this prospective randomized clinical comparative study, the investigators will compare the AF catheter ablation group and drug therapy group in terms of cognitive function tests and depression psychological tests at baseline and a year after treatment. Our hypothesis is that AF catheter ablation is superior to drug therapy to improve cognitive function and depressive mood.
Read the detailed description
Study design
- Prospective randomization (catheter ablation group vs. drug treatment group) (Python program is used, the random number module is imported using the import random syntax, and the random number table of the two groups is prepared and used)
- Target number of targets 320 (160 for each group)
- Cardiac rhythm follow-up: 2012 ACC/AHA/ESC guidelines (baseline, 3 months, every 6 months after Holter, Electrocardiogram when symptoms are present)
- Anticoagulant therapy follows 2014 ACC/AHA/ESC guidelines.
- Evaluation of MOCA score (cognitive function), CES-D score (depression), and GAD-7 score (anxiety) at baseline and a year after treatment, respectively.
- Evaluation of all adverse events occurring in each group, hospitalization rate, major cardiovascular attack, and mortality rate comparison
Progress and rhythm/ ECG follow-up
- Implemented in accordance with 2012 ACC/AHA/HRS guidelines for AF management
- Baseline MOCA, CES-D, and GAD-7 score evaluation
- Outpatient follow-up observation 1 to 2 weeks after the start of the procedure or medication
- Follow-up observation at intervals of 2 months, 6 months, and then every 6 months after starting the procedure or medication
- If the patient complains of arrhythmia symptoms, conduct an electrocardiogram at any time, and follow the rhythm with a Holter or event recorder.
- Follow-up MOCA, CES-D, and GAD-7 score evaluation
Follow-up observation
- All patients are scheduled to visit the outpatient clinic every 6 months after 1~2 weeks, 2 months, 6 months, and even if they have symptoms in the middle, they will be treated as an outpatient at any time.
- An ECG is administered at every outpatient visit. A 24-hour Holter or event recorder was administered for 1 year at intervals of 2, 6, and 6 months after the procedure (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 on a standard electrocardiogram, event electrocardiogram, or Holter, it is evaluated as recurrence. Recurrence within 3 months after the procedure is classified as early recurrence, and recurrence after 3 months is classified as clinical recurrence.
- Conditions
- Atrial Fibrillation
- Being tested
- Atrial fibrillation catheter ablation group, Medical therapy group
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial fibrillation catheter ablation groupProcedure or surgery
- Pulmonary vein isolation
- Additional treatment for lesions caused by non-pulmonary veins
- Esophageal temperature monitoring to prevent damage to the esophagus
- Evaluation of procedure time and radiofrequency ablation time
- Evaluation of complications after the procedure
- Rhythm follow-up after the procedure is conducted in accordance with the above study design.
- Conduct a survey on cognitive function and emotion before and 12 months after the procedure
Medical therapy groupDrug
- Use of beta-blockers or calcium channel blockers for pulse rate control
- Antiarrhythmic drugs are administered to patients with highly symptomatic atrial fibrillation symptoms even after pulse rate control.
- If symptoms are not controlled even with antiarrhythmic drugs, electrical conversion to restore sinus rhythm.
- To prevent cerebral infarction, maintain optimal anticoagulant therapy according to the risk score for cerebral infarction.
- Conduct a questionnaire on cognitive function and emotion before and 12 months after the procedure
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation catheter ablation group | Experimental | catheter ablation Receives: Procedure: Atrial fibrillation catheter ablation group |
| Medical therapy group | Active comparator | standard treatment include anti-arrhythmic drug Receives: Drug: Medical therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cognitive function, depression, and anxiety scale after catheter ablation or drug treatment after 1 year of randomization
Compasison of scale change using the Moca questionnaire.
Measured: 1 year
Changes in depression scale after catheter ablation or drug treatment after 1 year of randomization
Compasison of scale change using the CES-D questionnaire.
Measured: 1 year
Changes in anxiety scale after catheter ablation or drug treatment after 1 year of randomization
Compasison of scale change using the GAD-7 questionnaire.
Measured: 1 year
Secondary outcomes (3)
Differences according to AF type
Measured: 1year
Differences in adverse effects of ablation vs. medications
Measured: 1year
Differences in MACE, Death, and Readmission rate
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study startJun 2021 (estimated)
- Primary completion23 Feb 2026 (estimated)
- Study completion23 Feb 2026 (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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-Nam Pak, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942171
- Sponsor's protocol ID
- 4-2020-1488
- Status last verified
- Jun 2021
- First submitted
- 26 May 2021
- Last updated
- 28 Jun 2021
- 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 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMOTIon and COgNitive Function After Atrial Fibrillation Catheter Ablation vs. Medical Therapy; Randomized Clinical Trial (EMOTICON Trial)
- ClinicalTrials.gov ID
- NCT04942171
- Acronym / sponsor ID
- 4-2020-1488
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- 23 Feb 2026 (estimated)
- Study completion
- 23 Feb 2026 (estimated)
- First posted
- 28 Jun 2021 (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.
"Atrial fibrillation (AF) is an arrhythmic disease that increases especially in the elderly, increasing the risk of ischemic stroke by 5 times and is a major cause of dementia and cognitive impairment.
Cognitive dysfunction accompanying AF occurs regardless of the presence or absence of stroke, and AF itself is known to affect cognitive function.
However, since cognitive dysfunction is also affected by various accompanying chronic diseases, whether the cognitive dysfunction accompanying AF is due to subclinical ischemic stroke, cerebral hypoperfusion due to reduced cardiac output, inflammatory reaction or platelet dysfunction are unclear.
Recently, this research team reported an improvement in cognitive function with active sinus rhythm therapy such as AF catheter ablation. Nevertheless, it has not yet been proven whether such active and invasive AF treatment affects the improvement of cognitive function or depression by a randomized clinical trial.
In this prospective randomized clinical comparative study, the investigators will compare the AF catheter ablation group and drug therapy group in terms of cognitive function tests and depression psychological tests at baseline and a year after treatment. Our hypothesis is that AF catheter ablation is superior to drug therapy to improve cognitive function and depressive mood.
Detailed description
Study design
- Prospective randomization (catheter ablation group vs. drug treatment group) (Python program is used, the random number module is imported using the import random syntax, and the random number table of the two groups is prepared and used)
- Target number of targets 320 (160 for each group)
- Cardiac rhythm follow-up: 2012 ACC/AHA/ESC guidelines (baseline, 3 months, every 6 months after Holter, Electrocardiogram when symptoms are present)
- Anticoagulant therapy follows 2014 ACC/AHA/ESC guidelines.
- Evaluation of MOCA score (cognitive function), CES-D score (depression), and GAD-7 score (anxiety) at baseline and a year after treatment, respectively.
- Evaluation of all adverse events occurring in each group, hospitalization rate, major cardiovascular attack, and mortality rate comparison
Progress and rhythm/ ECG follow-up
- Implemented in accordance with 2012 ACC/AHA/HRS guidelines for AF management
- Baseline MOCA, CES-D, and GAD-7 score evaluation
- Outpatient follow-up observation 1 to 2 weeks after the start of the procedure or medication
- Follow-up observation at intervals of 2 months, 6 months, and then every 6 months after starting the procedure or medication
- If the patient complains of arrhythmia symptoms, conduct an electrocardiogram at any time, and follow the rhythm with a Holter or event recorder.
- Follow-up MOCA, CES-D, and GAD-7 score evaluation
Follow-up observation
- All patients are scheduled to visit the outpatient clinic every 6 months after 1~2 weeks, 2 months, 6 months, and even if they have symptoms in the middle, they will be treated as an outpatient at any time.
- An ECG is administered at every outpatient visit. A 24-hour Holter or event recorder was administered for 1 year at intervals of 2, 6, and 6 months after the procedure (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 on a standard electrocardiogram, event electrocardiogram, or Holter, it is evaluated as recurrence. Recurrence within 3 months after the procedure is classified as early recurrence, and recurrence after 3 months is 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 |
|---|---|---|
| Atrial fibrillation catheter ablation group | Experimental | Procedure: Atrial fibrillation catheter ablation groupcatheter ablation |
| Medical therapy group | Active comparator | Drug: Medical therapy groupstandard treatment include anti-arrhythmic drug |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged between 20 and 80 years of age who have appropriate indication for catheter ablation for AF
- AF patients with left atrium diameter <55 mm
- Antiarrhythmic drug-resistant AF
- Anticoagulation eligible patients
Key exclusion criteria (12 listed)
- AF associated with severe cardiac malformation or structural heart disease
- Patients undergoing treatment for cognitive disorders, emotional disorders, and anxiety disorders
- Patients with severe renal dysfunction or difficulty in CT imaging using contrast media
- Patients with a previous history of AF ablation or other open heart surgery
- Patients with active internal bleeding
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 |
|---|---|---|
| Atrial fibrillation catheter ablation group1. Pulmonary vein isolation 2. Additional treatment for lesions caused by non-pulmonary veins 3. Esophageal temperature monitoring to prevent damage to the esophagus 4. Evaluation of procedure time and radiofrequency ablation time 5. Evaluation of complications after the procedure 6. Rhythm follow-up after the procedure is conducted in accordance with the above study design. 7. Conduct a survey on cognitive function and emotion before and 12 months after the procedure | Procedure or surgery | Atrial fibrillation catheter ablation group |
| Medical therapy group1. Use of beta-blockers or calcium channel blockers for pulse rate control 2. Antiarrhythmic drugs are administered to patients with highly symptomatic atrial fibrillation symptoms even after pulse rate control. 3. If symptoms are not controlled even with antiarrhythmic drugs, electrical conversion to restore sinus rhythm. 4. To prevent cerebral infarction, maintain optimal anticoagulant therapy according to the risk score for cerebral infarction. 5. Conduct a questionnaire on cognitive function and emotion before and 12 months after the procedure | Drug | Medical therapy group |
Primary outcome
Changes in cognitive function, depression, and anxiety scale after catheter ablation or drug treatment after 1 year of randomization
Time frame: 1 year
Compasison of scale change using the Moca questionnaire.
Changes in depression scale after catheter ablation or drug treatment after 1 year of randomization
Time frame: 1 year
Compasison of scale change using the CES-D questionnaire.
Changes in anxiety scale after catheter ablation or drug treatment after 1 year of randomization
Time frame: 1 year
Compasison of scale change using the GAD-7 questionnaire.
3 secondary outcomes
Differences according to AF type
Time frame: 1year
Differences in adverse effects of ablation vs. medications
Time frame: 1year
Differences in MACE, Death, and Readmission rate
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
Not yet recruitingPhase 4
An Investigator-initiated, Prospective, Open-label, Multicenter Randomized Controlled Trial, Comparing the Efficacy of Sacubitril/Valsartan and Standard Treatment on Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients Without Hypertensive
Atrial Fibrillation (Persistent), Catheter Ablation
Active, not recruitingObservational study
Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Major Gastrointestinal Bleeding (MGIB)
Not yet recruiting
Paroxysmal Atrial Fibrillation Repeat Ablation Strategies With Durably Isolated Pulmonary Veins
Ablation Techniques, Atrial Fibrillation (Paroxysmal)
Recruiting
Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation
Atrial Fibrillation (AF)
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
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.
Hui-Nam Pak principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atrial fibrillation catheter ablation group and Medical therapy 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 4 inclusion and 12 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 28 Jun 2021. 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 Pak (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?
Changes in cognitive function, depression, and anxiety scale after catheter ablation or drug treatment after 1 year of randomization (time frame: 1 year). 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 28 Jun 2021.