The main objective of this study is to obtain more insight in the (human) mechanism underlying BVR by assessing the correlation between response of BVR to preload variation in study subjects (with and) without electrical remodelling (based on…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is beat to beat variability of repolarization (BVR)
measured as short term variability of the QT interval (STV QT) of 31
consecutive beats on a 12-leads surface ecg.
Secondary outcome
not applicable.
Background summary
Predicting which patients are at increased risk of repolarization dependent
ventricular arrhythmias remains challenging. A promising new
electrocardiographic predictor is beat to beat variability of repolarization
(BVR). Increased BVR is linked to an electrical remodeling process which makes
repolarization instable. However, the precise mechanism underlying BVR remains
unclear. Recent preclinical data suggest that ventricular preload variation
influences BVR. The effect of preload variation on BVR was different in animals
with and without electrical remodeling.
Study objective
The main objective of this study is to obtain more insight in the (human)
mechanism underlying BVR by assessing the correlation between response of BVR
to preload variation in study subjects (with and) without electrical
remodelling (based on structural heart disease).
Study design
Patients scheduled for an electrophysiological study (e.g. supraventricular
tachycardia ablation procedure) will be included in the study. Study subjects
must have a structural normal heart and therefore will have no electrical
remodelling. After the diagnostic and/or therapeutic procedure an atrial and
ventricular stimulation protocol will be performed. This stimulation protocol
is performed with catheters still in place after the electrophysiological
procedure and is comparable to the stimulations performed during the standard
procedure. It will include stimulation of the right atrium (RA) and right
ventricle (RV). During this stimulation protocol two electrocardiograms (ecg)
will be recorded; one during stable preload and one while the preload is varied
from beat to beat by beat to beat variation of the atrioventricular (AV) pacing
interval. These ecg*s will be analysed for the effect of preload variation on
BVR. Data collected from patients included in the current study will be
combined with data collected from the ongoing Opticare QLV study (METC nr
14-147, ABR = NL48172.041.14). The Opticare QLV study includes patients with
structural heart disease (electrical remodelling). These patients undergo the
same stimulation protocol to vary preload and ecg*s recorded simultaneously are
analysed for BVR as well. The response of BVR to preload variation will then be
compared between patients with and without electrical remodelling.
Study burden and risks
Obtaining more insight in the mechanism underlying the electrophysiological
parameter BVR could have implications for its use as a risk predictor of
ventricular arrhythmias. Moreover, it could initiate new medical and/or device
related therapies for repolarization dependent ventricular arrhythmias. The
stimulation protocol needed to test the influence of variable preload on BVR
will add approximately 10 to 15 minutes to the procedure. The study is
performed with catheters still in situ after the initial procedure and the
stimulation is comparable to the protocols used during the electrophysiological
procedure. Therefore it induces no additional risk. However, the study subject
will not benefit from participation to this study either.
Heidelberglaan 100 Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100 Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* *18 years of age
* Structural normal heart based on present clinical information (echocardiography, electrocardiogram)
* Indication for an electrophysiological procedure based on a narrow complex tachycardia (presumed);
o Concealed bypass
o Atrioventricular node re-entry tachycardia (AVNRT)
o Ectopic atrial tachycardia
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:;* Use of anti-arrhythmic medication
* Atrial fibrillation at time of the stimulation protocol.
* Any possibility of electrical remodelling of the ventricle;
o The presence of an antidrome circle tachycardia; Wolf Parkinsson White syndrome (as due to the pre-excitation of the ventricles over the bypass some ventricular electrical remodelling can be expected).
o History of persistent atrial fibrillation (AF); due to persistent AF the ventricles are stimulated irregularly and aberrant conduction could induce electrical remodelling of the ventricle.
o History of frequent ventricular extrasystoli.;Exclusion criteria after informed consent is signed;
o At time of the electrophysiological procedure an on-going narrow complex tachycardia (as this will intervene with the stimulation protocol and will make the ecg*s unsuitable for STV QT analysis).
o During the stimulation protocol a large number of ventricular extra systoles (*5) or any other reason making the ecg*s unsuitable for STV QT analysis (e.g. movement artefacts)
Design
Recruitment
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 | NL55230.041.15 |