To identify patients who are not suitable for S-ICD implantation based on QRS/T-morphology analysis during exercise, although they passed the QRS/T-morphology screening in rest.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Baseline demographics and ECG characteristics of patients with an unacceptable
QRS/T-morphology recorded with a special type of ECG during an exercise test
are compared to patients with an acceptable QRS/T-morphology.
Secondary outcome
None
Background summary
The subcutaneous implantable cardioverter-defibrillator (S-ICD) is an
attractive alternative for commonly used transvenous ICDs in patients who are
at risk for sudden cardiac death, because of the perceived lower complication
rate. However, recent studies demonstrated that especially some patients with
an S-ICD experience inappropriate shocks due to inappropriate sensing during or
shortly after exercise. The standard pre-implant QRS-morphology screening ECG
in rest, which has to be done in all patients with the S-ICD to assure
appropriate sensing, was in all cases deemed appropriate. It was noticed,
however, that during or shortly after exercise a different QRS/T-morphology
developed causing exercise-related inappropriate shocks caused by inappropriate
oversensing. So far, it is not known which patients are vulnerable for
inappropriate sensing during exercise and are therefore not suitable for S-ICD
implantation.
Study objective
To identify patients who are not suitable for S-ICD implantation based on
QRS/T-morphology analysis during exercise, although they passed the
QRS/T-morphology screening in rest.
Study design
This is an observational study without invasive measurements
Intervention
A special type of ECG during an exercise test using re-usable suction cup ECG
electrodes will be used to examine the suitability for a S-ICD.
Study burden and risks
No adverse events are expected, besides the standard risk for exercise-tests in
patients with cardiac diseases.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Young patients <40 yrs, patients with inherited arrhythmogenic syndromes (Brugada syndrome, long QT syndrome, catecholaminergic polymorphic ventricular tachycardia, hypertrophic cardiomyopathy and idiopathic VF, such as carriers of the DPP6 haplotype), patients with a QRS duration between 100 and 150ms on baseline ECG, patients with large T-waves on baseline ECG and other patients vulnerable for T-wave oversensing according to the literature
Exclusion criteria
Younger than 18 years
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 | NL44538.018.13 |