Atrial FibrillationNCT05231967
Bursa Postgraduate Hospital Department of Cardiology
An observational study of Atrial Fibrillation, run by Bursa Postgraduate Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Cardioversion
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2016to 30 Jun 2018
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persistent atrial fibrillation patients.
Who may be able to join
- persistent atrial fibrillation
- underwent successful electrical cardioversion
- suitable for echocardiographic imaging
- who agreed to participate in the study
Who cannot join
- 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
About this study
Official title: 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.
Read the 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).
- Conditions
- Atrial Fibrillation
- Being tested
- Cardioversion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioversionOther
In proper atrial fibrillation patients, cardioversion was performed to provide sinus rhythm
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation recurrence | Atrial fibrillation recurrence one month after cardioversion Receives: Other: Cardioversion | |
| Sinus rhythm continue | Sinus rhythm continue one month after cardioversion Receives: Other: Cardioversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
sinus rhythm continue one month after cardioversion
atrial fibrillation recurrence
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start10 May 2016
- Primary completion31 May 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Bursa Postgraduate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan ARI, Bursa Postgraduate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231967
- Sponsor's protocol ID
- Bursa Postgraduate Hospital AF
- Status last verified
- Jan 2022
- First submitted
- 29 Jan 2022
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of the Left Atrial Kinetic Energy for Atrial Fibrillation Recurrence
- ClinicalTrials.gov ID
- NCT05231967
- Acronym / sponsor ID
- Bursa Postgraduate Hospital AF
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bursa Postgraduate HospitalUniversity, hospital or other
- Study start
- 10 May 2016 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation recurrence | – | Other: CardioversionAtrial fibrillation recurrence one month after cardioversion |
| Sinus rhythm continue | – | Other: CardioversionSinus rhythm continue one month after cardioversion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persistent atrial fibrillation patients.
Key inclusion criteria (4 listed)
- persistent atrial fibrillation
- underwent successful electrical cardioversion
- suitable for echocardiographic imaging
- who agreed to participate in the study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioversionIn proper atrial fibrillation patients, cardioversion was performed to provide sinus rhythm | Other | Atrial fibrillation recurrence, Sinus rhythm continue |
Primary outcome
sinus rhythm continue one month after cardioversion
Time frame: one month
atrial fibrillation recurrence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Bursa Postgraduate Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sinus rhythm continue one month after cardioversion (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.