Cardiac Stunning After Electrical Cardioversion

NCT06752733 | Active Not Recruiting

• 1 other identifier: 2020GR0213
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Outcome Measures

Primary Outcomes (1)

• The recurrence of atrial arrhythmia

  From enrollment to the end of treatment at 12 months

Study Arms (1)

Atrial fibrillation

A group of patients with atrial fibrillation refractory to pharmacological treatment who are candidates for electrical cardioversion

Procedure: electrical cardioversion

Interventions

electrical cardioversion PROCEDURE

synchronized electrical shocks to restore normal sinus rhythm in patients with atrial fibrillation, performed under sedation

Atrial fibrillation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Korea University College of Medicine, Guro Hospital

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Korea University Medicine Guro hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electric Countershock

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: December 31, 2024
• Study Start: February 20, 2024
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)