Tachycardia, Ventricular
Conditions
Brief summary
The study purpose is to demonstrate that ventricular tachycardia (VT) ablation using the Niobe™ ES system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT in a low ejection fraction population.
Detailed description
This study is a randomized, single-blind, prospective, multi-center post market evaluation. Subjects will be screened for study eligibility and asked to complete written informed consent prior to any study specific testing assessments. After completing written informed consent, a total of 386 subjects will be randomized on a 1:1 basis to receive VT ablation treatment using either the Niobe ES or standard manual catheter ablation treatment using commercially available products. This will be the largest randomized VT study comparing outcomes from RMN to manually guided catheter ablation procedures. Subjects will be randomized according to a computer-generated randomization scheme. Randomization will be blocked at the study site level and subjects will be blinded to group assignment. Since quality of life measurements will be collected during follow-up, this study is single-blinded in order to mitigate patient bias. Clinical evaluations will not be masked to the treating physician.
Interventions
DEVICEcatheter ablation using magnetic navigation
elimination of cardiac arrhythmias through heating and destroying heart tissue with faulty electrical pathways through the use of Stereotaxis's Niobe ES System with the NaviStar RMT ThermoCool catheter or other magnetically compatible catheters.
DEVICEcatheter ablation using manual navigation
elimination of cardiac arrhythmias through heating and destroying heart tissue with faulty electrical pathways through the use of the NaviStar ThermoCool catheter or other manually navigated catheters.
Sponsors
Stereotaxis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* subject has had an ICD previously implanted * subject has drug-refractory monomorphic VT * subject is a candidate for ischemic VT RF ablation * subject has had a myocardial infarction * subject has a LVEF less than or equal to 35%
Exclusion criteria
* subject has non-ischemic VT * subject has a history of stroke within 1 month prior to enrollment * subject has had an acute myocardial infarction within 30 days prior to enrollment * subject has unstable angina * subject has undergone cardiac surgery within 60 days prior to enrollment * subject is pregnant or nursing * subject has a 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.) * subject is unable or unwilling to cooperate with study procedures * subject has a known presence of intracardiac thrombi as determined by echocardiography * subject has a major contraindication to anticoagulation therapy or coagulation disorder * subject has had a previous pericarditis or cardiac tumor * subject has had previous thoracic radiation therapy * any other reason the investigator considers the subject ineligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| freedom from any VT in the overall cohort | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| acute success of procedure | at end of procedure (immediate) | non-inducibility of clinical VT and/or other monomorphic VT using typical stimulation protocol for induction |
| freedom from VT in large scar subpopulation | 12 months | — |
| major adverse events | 48 hours post-procedure | death, cardiac tamponade, stroke, bleeding requiring surgical intervention, progressive heart failure related to VT/VF recurrence |
| mortality rate | 12 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total mapping time | through end of acute procedure, an average of 3 hours | — |
| Total ablation time | through end of acute procedure, an average of 3 hours | — |
| Total number of appropriate ICD defibrillator shocks | 12 months | — |
| Total ablation energy delivery | through end of acute procedure, an average of 3 hours | Watts X seconds / Total scar surface area |
| Patient quality of life (SF-12) | 12 months | Medical Outcomes Study 12-item Short-Form Health Survey |
| Total mapping points prior to ablation | through end of acute procedure, an average of 3 hours | — |
| Total number of ICD applications of anti-tachycardia pacing | 12 months | — |
| Total procedure time (skin to skin) | through end of acute procedure, an average of 3 hours | — |
| Total fluoroscopy time | through end of acute procedure, an average of 3 hours | — |
| Total fluoroscopy dose | through end of acute procedure, an average of 3 hours | — |
Countries
Australia, Belgium, Czechia, Denmark, France, Netherlands, United States
Outcome results
None listed