Comparison of a short versus the conventional stimulation protocol for ventricular arrhythmia induction in patients with non-ischemic cardiomyopathy.
Recruiting
- Conditions
- induction of ventricular arrhythmias10007521
- Registration Number
- NL-OMON45986
- Lead Sponsor
- niversitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 134
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study endpoints are 1) Reproducible induction (two times) of sustained<br /><br>monomorphic VT (lasting longer than 30 seconds or requiring immediate<br /><br>termination because of hemodynamic instability), 2) Induction of two episodes<br /><br>of polymorphic VT or VF requiring cardioversion or 3) Non inducibility of any<br /><br>sustained VA from two ventricular sites.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints of the study are:<br /><br>- to compare the efficiency (in terms of time-to-induction or to<br /><br>time-to-complete the induction protocol) of the conventional versus short<br /><br>protocol of induction.<br /><br>- in patients scheduled for endocardial VT ablation, the additional yield of<br /><br>induction from a left ventricular (LV) site will be tested<br /><br>- in patients scheduled for endo- and epicardial VT ablation, the additional<br /><br>yield of induction from an epicardial site will be tested </p><br>