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

NCT04942171 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2021-06-28

No results posted yet for this study

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

Interventions

PROCEDURE

Atrial fibrillation catheter ablation group

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

DRUG

Medical therapy group

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Hui-Nam Pak · Yonsei University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2026-02-23
Completion
2026-02-23

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04942171 on ClinicalTrials.gov