(1) Establishing normal values (cut-offs) for bipolar and unipolar voltage mapping during sinus rhythm and pacing. (2) Establish normal values for conduction velocity during sinus rhythm of the 4 chambers. (3) Establish normal values for activation…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: electrophysiological data, device success,
adverse effects and comparability with the current mapping approach and
substrate identified by CE-MRI.
Secondary outcome
Not applicable.
Background summary
Electro-anatomical mapping (EAM) with standard large tip, bipolar catheters is
time consuming and provides limited information. Multi-electrode mapping has
several advantages, especially if grid electrodes are used with fixed distances
and pacing modalities. Bipolar signals can easily be constructed mathematically
and local activation pattern, anisotropic conduction properties and fibrosis
can be revealed. The latter is likely a key player in arrhythmogenity and
identifying areas with abnormal conduction is of importance for substrate based
ablation procedures. In this protocol the HD Ensite Grid Catheter will be used
for these purposes.
Study objective
(1) Establishing normal values (cut-offs) for bipolar and unipolar voltage
mapping during sinus rhythm and pacing. (2) Establish normal values for
conduction velocity during sinus rhythm of the 4 chambers. (3) Establish
normal values for activation recovery intervals as substitute for action
potential duration (APD) and APD restitution curves to evaluate local/global
dispersion of repolarization. (4) Evaluate the influence of the direction of
the activation wavefront on electogram amplitude, duration and conduction
velocity during pacing from 2 orthogonal located pairs at fixed conduction
velocity (CL) and during premature extrastimuli (anisotropic conduction). (5)
Comparing voltage and activation mapping data obtained with the HD grid
catheter with data acquired with a conventional 4mm tip catheter (Ensite). (6)
Comparing procedure time required to obtain high density maps with conventional
versus HD grid catheters.
In a second step we would like to compare the electrophysiological substrate
characteristics of patients with complex arrhythmias with the current gold
standard in imaging to detect fibrosis which is contrast enhanced cardiac MR.
Study design
a prospective, single-arm study.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: This is a first-in-man study and therefore no
previous clinical experience in human is available for the use of the HD Ensite
Grid Catheter. Comparable catheters with the same material are used in clinical
practice. This catheter, which is only a diagnostic tool, has a different
design compared to existing multielectrode catheters.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- Patients who are electively scheduled for a first catheter ablation to treat an atrial of ventricular arrhythmia.
- Patient understands the implications of participating in the study and provides informed consent
Exclusion criteria
- Previous surgical of catheter ablation of the atria or ventricle
- Patients with uncontrolled heart failure or with NYHA class > II
- Patients with stable/unstable angina or myocardial ischemia
- Patients with infection
- Patients with severe co-morbidity or poor general physical/mental health
- Patients with contra - indications for cardiac MRI
Design
Recruitment
Medical products/devices used
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 | NL60897.058.17 |