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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Atrial fibrillation recurrence
Atrial fibrillation recurrence one month after cardioversion
Other: Cardioversion
In proper atrial fibrillation patients, cardioversion was performed to provide sinus rhythm
Sinus rhythm continue
Sinus rhythm continue one month after cardioversion
Other: Cardioversion
In proper atrial fibrillation patients, cardioversion was performed to provide sinus rhythm

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bursa Postgraduate 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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