This study has three objectives:1. To describe flow patterns in the left atrium in patient with sinus rhythm and atrial fibrillation. 2. To prospectively verify the data in patients with atrial fibrillation3. Correlation of abnormal flow patterns to…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Flow patterns in the left atrium in different patient groups.
Secondary outcome
Not applicable
Background summary
Atrial fibrillation (AF) is a risk factor for the occurrence of embolism
leading to stroke. Stroke is associated with an increase in medical cost and
high mortality and morbidity. Estimating the risk of stroke can be challenging.
The choice of medication, antiplatelet therapy or vitamin K antagonists is very
important. The prior is used in cases of low risk of embolism and has not many
side effects. The latter is used in patients with high risk of embolism and has
serious side effects.
At this moment the medication choice is based on clinical risk factors as
described in the CHA2DS2-VASc score. This study tries to individualize the use
of anticoagulants and thereby prevent major side effects.
Echocardiography can supply data to make a better choice for the type of
anticoagulants. It is known that an abnormal flow pattern in the left ventricle
can predict thrombus formation in the apex. There is little information about
flow patterns in the left atrium. However in individual patients we have seen
abnormal flow patterns.
The hypothesis of this study is that just like in the left ventricle, an
abnormal flow pattern of the left atrium can predict thrombus formation in both
the left atrium and left atrial appendix.
Study objective
This study has three objectives:
1. To describe flow patterns in the left atrium in patient with sinus rhythm
and atrial fibrillation.
2. To prospectively verify the data in patients with atrial fibrillation
3. Correlation of abnormal flow patterns to stroke
Study design
A mono-center prospective, cross section, observational follow-up study. Study
duration has been defined as a maximum of five years follow-up. In this study
the patient is its own control.
Study burden and risks
The patients will undergo a transesofageal echo. For patient in group 1 and 3
this is standard medical care. For the patients in group 2 TEE will be
performed before and after electrocardioversion. These patiënts are sedated.
The TEE will elongate the duration of anaesthesia with an estimed 5-10 minutes.
For the groups 3 and 4 an extra TEE will be performed. During TEE some throat
discomfort and dyspnea can be experienced. During TEE there is ECG monitoring.
ECG-stickers can cause allergic reactions. Patients should be sober for at
least 6 hours.
Leyweg 275
2545 CH Den Haag
NL
Leyweg 275
2545 CH Den Haag
NL
Listed location countries
Age
Inclusion criteria
Age range from 18 to 80 years
At least one documented episode of atrial fibrillation
Able to give informed consent
No contra-indications for trans esophegeal ultrasound examination
No contra-indication for cardioversion
No contra-indication for pulmonary vein isolation or mini-MAZE
Exclusion criteria
Unable to give informed consent
Prior myocardial infarction
Life expectation * 1 year
left ventricular dysfunction
Medical history of stroke or embolisation
Left ventricular thrombus
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39691.098.12 |