Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02647749 |
| Other study ID # |
CHUBX 2015/01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 19, 2015 |
| Est. completion date |
May 28, 2020 |
Study information
| Verified date |
February 2022 |
| Source |
University Hospital, Bordeaux |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This current care protocol follows the biomedical research protocol entitled "Non-invasive
mapping of the heart ECG high amplification" that demonstrated the clinical value of
noninvasive Cardioinsight® mapping system.
Guide the management of patients hospitalized for cardiac rhythm radiofrequency ablation of
cardiac arrhythmias, implantation or programming of a pacemaker, or assess the risk of
serious arrhythmias or sudden death, with the currently used non-invasive mapping routine.
The results obtained with non-invasive mapping will be compared with those obtained with the
conventional method without non-invasive mapping.
Description:
This current care protocol is for 3 groups of patients :
1. Role of mapping arrhythmias before radiofrequency ablation :
Radiofrequency ablation is a treatment of atrial or ventricular arrhythmias resistant to
drug treatment. The electrocardiogram does not allow a full diagnosis of arrhythmias and
it appears difficult to get a comprehensive and simultaneous view of cardiac activity
during invasive maps. The Investigators have demonstrated the feasibility of mapping
atrial fibrillation and its usefulness to guide radiofrequency ablation. The
non-invasive mapping would allow a better understanding of complex cardiac arrhythmias
mechanism (atrial fibrillation, ventricular tachycardia and ventricular fibrillation in
particular), would identify the arrhythmogenic sites and thus facilitate radiofrequency
ablation.
2. Optimizing the site of implantation of cardiac pacing leads and programming the
pacemaker:
The optimal position of the cardiac pacing leads may vary from one patient to another
and the current choice of implantation sites is essentially guided by imaging and does
not use power requirements because of the inadequacies of the ECG standard. The
Investigators have already demonstrated the usefulness of non-invasive mapping in the
selection of potential responders to cardiac resynchronization therapy. The non-invasive
mapping would study the cardiac electrical activation in order to determine the optimal
pacing sites and optimum programming according to each patient and thus improve the
clinical response to pacing.
3. Role diagnostic and prognostic for patients referred for evaluation of the risk of
occurrence of a serious rhythm disorder or sudden death :
The possibility to identify electrically abnormal areas either during the activation, or
during cardiac repolarization with the high-resolution ECG is an indication of myocardial
pathology that can be both unapparent on standard ECG and inaccessible to imaging techniques
(ultrasound, CT or MRI). It is likely that such electrical anomalies are early diagnostic
features of heart disease that will later be apparent. Such anomalies can also have an
adverse prognostic weight (risk of arrhythmias or sudden death) that can be corrected if it
is highlighted. Non-invasive mapping seems particularly important in patients with
unexplained symptoms by conventional tests (palpitations or discomfort - syncope). It will
also be applicable to patients with heart disease (myocardial infarction, cardiomyopathy) in
search of localized electrical disorders that can be an originating site of arrhythmia.
