To assess whether atrial flow patterns during sinus rhythm in patients with atrial fibrillation differ from healthy controls with sinus rhythm.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome of this study will be the presence of atrial vortex flow,
vortex properties, and particle traces in the left atrium as visualized and
quantified by 4D flow CMR.
Secondary outcome
Secondary endpoints will be left atrial fibrosis as detected by CMR and left
atrial function derived from combining the volumetric measurements on CMR with
invasive pressure measurements acquired during pulmonary vein isolation(PVI)
procedure in patients with paroxysmal/persistent AF.
Background summary
Atrial fibrillation (AF) increases the risk for thromboembolic events, mainly
ischemic stroke. Several mechanisms in AF lead to blood stasis, causing a
thromboembolic environment. In patients with AF thrombi are formed, which are
washed out to the periphery and the brain. It is conceivable that atrial flow
in paroxysmal AF patients is also impaired when in SR. Probable mechanisms
include structural remodeling/fibrosis of the left atrium (LA), mechanical
discordance of the left atrial appendage (LAA) all leading to altered atrial
hemodynamics. Studies using 4-dimensional (4D) cardiac magnetic resonance
imaging (CMR) have shown vortical flow patterns in healthy atria. The present
study will serve as a pilot to determine differences in atrial flow patterns
during SR between patients with paroxysmal AF, persistent AF and healthy
volunteers with SR using 4D flow CMR.
Study objective
To assess whether atrial flow patterns during sinus rhythm in patients with
atrial fibrillation differ from healthy controls with sinus rhythm.
Study design
Observational cohort study, cross sectional
Intervention
All participants will undergo a fluid challenge during the CMR exam with
intravenous administration of 500ml NaCl 0.9%.
Patients with AF will undergo the same fluid challenge during PVI treatment as
well.
Study burden and risks
All patients will undergo CMR with late gadolinium-enhancement and a fluid
challenge with intravenous 500ml NaCl 0.9% in 10 min. Atrial fibrillation
patients who are already scheduled for PVI, will have additional atrial
pressure measurements during PVI before and after a similar fluid challenge.
The risks are minimal. Gadolinium is a very safe contrast agent, which is
frequently used in clinical practice. Intravenous gadolinium administration may
cause minimal injection site reactions (e.g. pain, cold or burning sensation).
As with other contrast-agents, anaphylactic-like reactions can occur, although
this is very unusual. For safety reasons a medical doctor will be present
during the scanning sessions to monitor the patient*s status. Patients with a
known (suspected) allergic reaction to gadolinium or severe kidney failure (GFR
<30 ml/min/kg) will be excluded.
For healthy volunteers all study elements are extra (MRI scan en
echocardiography). For them the burden consists mainly of an investment of
their time. The associated risks are neglible (gadolinium contrast agent as
described above and intravenous 500ml NaCl 0.9% has no expected side
effects/risks).
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
Atrial fibrillation (AF) groups: paroxysmal AF (defined as AF with spontaneous termination within seven days) OR persistent AF (defined as not self-terminating AF lasting more than 7 days, but not permanent AF); scheduled for pulmary vein isolation treatment
Healthy controls: No history of cardiac disease
Exclusion criteria
All subjects: age under 18 or greater than 75 years; clinically significant valvular disease; left ventricular ejection fraction <50%; severe kidney failure (defined as GFR<60 ml/min/kg); electrical cardioversion <6 weeks prior to inclusion; contra-indication for MRI (i.e. implantable devices, claustrophobia, ocular metallic foreign body, metallic brain clips), known contrast allergy (gadolinium)
Additional for AF patients: atrial fibrillation on ECG on the day of MRI exam
Additional for healthy controls: structural heart disease on echocardiography
Design
Recruitment
Medical products/devices used
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 | NL54302.029.15 |