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OpenTrials
Completed

NCT Number: NCT05231967

Bursa Postgraduate Hospital Department of Cardiology

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardioversion

Other

In proper atrial fibrillation patients, cardioversion was performed to provide sinus rhythm

Primary outcomes

  1. sinus rhythm continue one month after cardioversion

    Time frame: one month

    atrial fibrillation recurrence

Sponsors and collaborators

Lead sponsor

Bursa Postgraduate Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 9, 2022
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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