Non-invasive localization of the origin of idiopathic ventricular arrhythmias
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
First, measure of agreement between the calculated origin of ventricular
arrhythmia via our mathematical model versus observed origin of ventricular
arrhythmia as Rhythmia© mapping system.
Second, accuracy of the NI-ECG in predicting the origin of ventricular
arrhythmia by calculating the difference in millimetres between observed site
of origin and calculated site of origin.
Secondary outcome
N.a.
Background summary
Idiopathic ventricular arrhythmias mostly originate in the outflow area of the
heart.
This is a complex anatomic area consisting of the right ventricular outflow
tract, pulmonic artery, left ventricular outflow tract, aortic cusps, coronary
sinus as well as the coronary veins, mitral annulus and epicardial anterior
crux.
Detailed data on the site of origin obtained by a non-invasive mapping tool,
such as integrated electrocardiographic mapping, prior to the procedure may
facilitate future mapping procedure by narrowing down the number of potential
anatomical structures from which the ventricular ectopy may originate. Thus,
procedure time can be shortened in addition to achieving a reduction in the
number of anatomical structures that needs to be mapped invasively.
Study objective
Non-invasive localization of the origin of idiopathic ventricular arrhythmias
Study design
Observational study
Intervention
Patients who are scheduled to undergo radiofrequency ablation of symptomatic,
idiopathic ventricular ectopy are eligible for this study. All patients will
undergo cardiac magnetic resonance imaging (MRI) as part of standard workup
before ablation.
Prior to electrophysiology study, an extended, 64-channel, body surface
electrocardiogram of the spontaneous ventricular ectopy will be obtained. This
ECG-data combined with findings of cardiac MRI will be fed into a mathematical
model, capable of reconstructing epicardial and endocardial activation maps, to
estimate the site of origin of the ventricular ectopy.
Study burden and risks
Patients will have to undergo one additional, extended body surface
electrocardiographic (ECG) registration by means of a 64-electrode set. The
cardiac images obtained with the clinically indicated MRI will be used to
reconstruct cardiac and thoracic anatomy as well as geometry. There is no
additional risk to our patient population, since no additional invasive
procedures are required.
All patients will receive standard care prior to, during and after procedure.
No direct personal benefit can be gained from participating in this study. Our
participants do contribute to knowledge regarding the use of our specific body
surface mapping system.
Koningstraat 1
Enschede 7512KZ
NL
Koningstraat 1
Enschede 7512KZ
NL
Listed location countries
Age
Inclusion criteria
1) Patients, without demonstrable cardiac disease, scheduled for elective radiofrequency catheter ablation of symptomatic, ventricular monomorphic tachycardia and/or extrasystole
2) Age 18 years and older
Exclusion criteria
1) Unwillingness to participate in study or sign informed consent
2) Linguistic barrier in communication
3) Unable to undergo cardiac MRI (cardiac device, claustrophobia, implants)
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 | NL68262.044.18 |
| Other | nog niet toegewezen |