Cardiac Stunning After Electrical Cardioversion (AMPEA)

December 23, 2024 updated by: Roh Seung Young, Korea University Guro Hospital

The Association Between Myocardial Stunning and Long-term Prognosis After Electrical Cardioversion in Patients with Atrial Fibrillation

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Korea University College of Medicine, Guro Hospital

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Atrial fibrillation
A group of patients with atrial fibrillation refractory to pharmacological treatment who are candidates for electrical cardioversion
Procedure: electrical cardioversion
synchronized electrical shocks to restore normal sinus rhythm in patients with atrial fibrillation, performed under sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The recurrence of atrial arrhythmia
Time Frame: From enrollment to the end of treatment at 12 months
From enrollment to the end of treatment at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Guro Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2024

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

December 23, 2024

First Submitted That Met QC Criteria

December 23, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020GR0213

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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