A prospective, multi-center, post market randomized controlled trial comparing VT ablation outcomes using remote MAGNETIC navigation guided substrate mapping and ablation versus manual approach in a low LVEF populatio

Phase 4

Completed

Conditions: cardiac arrythmia
ventricular tachycardia
10007521

Registration Number: NL-OMON43344

Lead Sponsor: Stereotaxis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Freedom from any recurrence of VT through 12 months. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>2. Acute Success: Defined as non-inducibility of clinical VT and/or other<br /><br>monomorphic VT, using typical stimulation protocol for induction, up to 3<br /><br>extra-stimuli brought in to ventricular refractoriness at 2 drive cycle<br /><br>lengths, in two sites).<br /><br>3. Freedom from any VT at 1 year in a large scar subpopulation (defined as<br /><br>patients with a scar total surface area > the median scar total surface area<br /><br>for the total population as determined by electroanatomic mapping).<br /><br>4. Procedure related major adverse events defined as death, cardiac tamponade,<br /><br>stroke, and bleeding requiring surgical intervention through 48 hours<br /><br>post-procedure, and progressive heart failure related to VT/VF recurrence<br /><br>within 48 hours post-ablation.<br /><br>5. Mortality rate through 12-months follow-up </p><br>