Bursa Postgraduate Hospital Department of Cardiology

January 29, 2022 updated by: Hasan ARI, Bursa Postgraduate Hospital

The Predictive Value of the Left Atrial Kinetic Energy for Atrial Fibrillation Recurrence

Ensuring and maintaining normal sinus rhythm is critical for reducing negative outcomes in patients with atrial fibrillation (AF). Electrical direct current cardioversion is a frequently used method of restoring SR, but a significant proportion of patients later develop AF recurrence. Determining which of these patients is prone to recurrence is important for treatment modification. Left atrial kinetic energy (LAKE) is a parameter that shows left atrial mechanical function and can be calculated noninvasively by transthoracic echocardiography. LAKE is reduced in patients with AF recurrence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study population: The study was initiated after the ethics committee of Bursa Postgraduate Hospital approved the study protocol. A total of 120 consecutive patients aged 18 years and older who underwent successful electrical cardioversion following persistent atrial fibrillation (AF) were included in the study. Persistent AF was defined as continuous AF lasting longer than seven days in electrocardiography follow-up (9). Patients with significant valvular disease, previous valve surgery, severe left ventricular systolic dysfunction (ejection fraction < 40%), severely dilated left atrium (> 5 cm), previous ablation of atrial fibrillation, or paroxysmal atrial fibrillation were excluded from the study.

The patients were divided into two groups - patients who remained in sinus rhythm (SR) (group 1) and patients with AF recurrence (group 2) after one month of follow-up.

Echocardiography: All patients underwent routine transthoracic echocardiography (TTE) prior to cardioversion and transoesophageal echocardiography (TEE) (EPIQ 7 Echocardiography Machine, Philips Ultrasound, Netherlands) to exclude left atrial and left atrial appendage thrombus. TTE was repeated in patients who remained in SR 24 hours after cardioversion. All standard measurements were taken from the parasternal long and short axes and apical two- and four-chamber windows. All assessments and measurements were made according to the American Society of Echocardiography (ASE) guidelines (10).

Left ventricular ejection fraction (LVEF) was calculated according to the modified biplane Simpson method (10). Mitral flow velocities were recorded from the apical four-chamber view with a sample volume of 5 mm placed at the level of the mitral valve tips using pulsed-wave Doppler (PWD). Peak early (E) and late (A) mitral entry velocities were recorded.

LAKE (left atrial kinetic energy) values were calculated at the 24th hour after cardioversion. LAKE was defined as 0.5 × left atrium stroke volume (cm³, volume at the beginning of left atrial systole - left atrium minimal volume) × 1.06 (g/cm³, blood density) × (peak A velocity)² (cm/sec, transmitral PWD A velocity) (8).

Study Type

Observational

Enrollment (Actual)

120

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Persistent atrial fibrillation patients.

Description

Inclusion Criteria:

  • persistent atrial fibrillation
  • underwent successful electrical cardioversion
  • suitable for echocardiographic imaging
  • who agreed to participate in the study

Exclusion Criteria:

  • significant valvular disease,
  • previous valve surgery,
  • severe left ventricular systolic dysfunction (ejection fraction < 40%),
  • severely dilated left atrium (> 5 cm),
  • previous ablation of atrial fibrillation, or paroxysmal atrial fibrillation

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 recurrence
Atrial fibrillation recurrence one month after cardioversion
In proper atrial fibrillation patients, cardioversion was performed to provide sinus rhythm
Sinus rhythm continue
Sinus rhythm continue one month after cardioversion
In proper atrial fibrillation patients, cardioversion was performed to provide sinus rhythm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sinus rhythm continue one month after cardioversion
Time Frame: one month
atrial fibrillation recurrence
one month

Collaborators and Investigators

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

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)

May 10, 2016

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

January 29, 2022

First Submitted That Met QC Criteria

January 29, 2022

First Posted (Actual)

February 9, 2022

Study Record Updates

Last Update Posted (Actual)

February 9, 2022

Last Update Submitted That Met QC Criteria

January 29, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Bursa Postgraduate Hospital AF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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