cardiac arrythmia ventricular tachycardia
Conditions
Interventions
The ablation of ventricular arrhythmias is a standard treatment in specialized
hospitals. In this trial the patients will be randomized between two ablation
techniques
the conventional manual approach and the approach where the
ablation occurs by means of magnetical navigation where the catheters are
guided through magnets (MN, Magnet Navigation). MN exists for ye
Sponsors
Stereotaxis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient is 18 years of age or older; 2. Patient has provided written informed consent; 3. Patient has an implantable cardioverter defibrillator (ICD) previously implanted; 4. Drug refractory monomorphic VT; 5. Patient is a candidate for ischemic VT RF ablation; 6. Patient has had a myocardial infarction; 7. LVEF * 35%.
Exclusion criteria
Exclusion criteria: 1. Non-ischemic VT; 2. History of stroke within 1 month prior to enrollment; 3. Acute MI within 30 days prior to enrollment; 4. Unstable angina; 5. Cardiac surgery within 60 days prior to enrollment; 6. Patient is pregnant or nursing; 7. Limited life expectancy of 1 year or less (Subjects requiring LVAD/IABP intraprocedural support may be enrolled as long as life expectancy is at least 1 year following the ablation procedure.) 8. Patient is unable or unwilling to cooperate with the study procedures; 9.. Known presence of intracardiac thrombi determined by echocardiography; 10. Major contraindication to anticoagulation therapy or coagulation disorder; 11. Previous pericarditis or cardiac tumor; 12. Previous thoracic radiation therapy; 13. Any other reason the investigator considers the subject ineligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Freedom from any recurrence of VT through 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Acute Success: Defined as non-inducibility of clinical VT and/or other monomorphic VT, using typical stimulation protocol for induction, up to 3 extra-stimuli brought in to ventricular refractoriness at 2 drive cycle lengths, in two sites). 3. Freedom from any VT at 1 year in a large scar subpopulation (defined as patients with a scar total surface area > the median scar total surface area for the total population as determined by electroanatomic mapping). 4. Procedure related major adverse events defined as death, cardiac tamponade, stroke, and bleeding requiring surgical intervention through 48 hours post-procedure, and progressive heart failure related to VT/VF recurrence within 48 hours post-ablation. 5. Mortality rate through 12-months follow-up | — |
Countries
Netherlands
Outcome results
None listed