The primary objective of this study is to compare prospectively, in a randomized fashion, the sensitivity and specificity of the conventional versus a short stimulation protocol for induction of sustained monomorphic VT in patients with NICM.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoints are 1) Reproducible induction (two times) of sustained
monomorphic VT (lasting longer than 30 seconds or requiring immediate
termination because of hemodynamic instability), 2) Induction of two episodes
of polymorphic VT or VF requiring cardioversion or 3) Non inducibility of any
sustained VA from two ventricular sites.
Secondary outcome
The secondary endpoints of the study are:
- to compare the efficiency (in terms of time-to-induction or to
time-to-complete the induction protocol) of the conventional versus short
protocol of induction.
- in patients scheduled for endocardial VT ablation, the additional yield of
induction from a left ventricular (LV) site will be tested
- in patients scheduled for endo- and epicardial VT ablation, the additional
yield of induction from an epicardial site will be tested
Background summary
In patients with coronary artery disease, a short 6-step stimulation protocol
for the induction of ventricular arrhythmias (VA) consisting on the application
of 4 extrastimuli only has been demonstrated to be as sensitive while more
specific than the conventional protocol which includes the application of 1 to
3 extrastimuli in a sequential fashion. Whether these results are applicable to
patients with non-ischemic cardiomyopathy (NICM) is unknown.
Study objective
The primary objective of this study is to compare prospectively, in a
randomized fashion, the sensitivity and specificity of the conventional versus
a short stimulation protocol for induction of sustained monomorphic VT in
patients with NICM.
Study design
This is a single-center open randomized controlled study.
Intervention
Both the conventional and the short protocol will be performed in each study
patient. The order in wich the protocols are performed will be determined in a
random fashion. If sustained monomorphic VT or VF is induced, or if the
protocol is completed without induction of VAs, the reproducibility of
induction will be tested with the second protocol.
Study burden and risks
In all patients, the electrophysiological study will be clinically indicated,
therefore, there are not additional burden of risks to participants. Patients
included in the study may benefit from a shortened protocol of induction with a
lower rate of induction of VF.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Patients with left-dominant NICM with previous documentation of sustained VA (sustained monomorphic VT or VF) or clinically considered to be at high risk for VA (presenting with palpitations or syncope with/or without documented non-sustained VT) scheduled for electrophysiological study with/or without ablation.
Exclusion criteria
- Age < 18 years
- Inadequate patient competence
- Pregnancy
- Inability to comply with the protocol due to haemodynamic instability
- Non-NICM (e.g., prior myocardial infarction, infiltrative cardiac disease such as sarcoidosis, amyloidosis or Chagas cardiomyopathy, arrhythmogenic RV cardiomyopathy/dysplasia, hypertrophic cardiomyopathy, non-compaction cardiomyopathy and congenital heart disease)
Design
Recruitment
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 | NL66415.058.18 |