EMOTIon and COgNitive Function After Atrial Fibrillation Catheter Ablation vs. Medical Therapy(EMOTICON Trial)

NCT04942171 | Not Yet Recruiting DMC

• 1 other identifier: 4-2020-1488
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  1 year

Secondary Outcomes (3)

• Differences according to AF type

  1year

• Differences in adverse effects of ablation vs. medications

  1year

• Differences in MACE, Death, and Readmission rate

  1year

Study Arms (2)

Atrial fibrillation catheter ablation group

EXPERIMENTAL

catheter ablation

Procedure: Atrial fibrillation catheter ablation group

Medical therapy group

ACTIVE COMPARATOR

standard treatment include anti-arrhythmic drug

Drug: Medical therapy group

Interventions

Atrial fibrillation catheter ablation group PROCEDURE

1. 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

Atrial fibrillation catheter ablation group

Medical therapy group DRUG

1. 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

Medical therapy group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hui-Nam Pak

  Yonsei University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Nam Pak

CONTACT

82-2-2228-8459; hnpak@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 28, 2021
• Study Start: June 1, 2021
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: June 28, 2021

Record last verified: 2021-06

Locations

KR (1)