Ischemic Ventricular Tachycardia
Conditions
Brief summary
This is a prospective, non-randomized study to determine the feasibility of using a new technique called Dynamic Substrate Mapping (DSM) to help guide the treatment of ischemic ventricular tachycardia (IVT). We hypothesize that DSM will lead to simpler, more effective ablation of IVT. Results from this study will be used to determine if further clinical investigation is warranted.
Interventions
DEVICEDynamic Substrate Mapping-guided ablation
Radiofrequency ablation
Sponsors
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Have an ICD or CRT-D device * Had at least 3 documented device therapies to treat VT over last 3 months * Clinical VT is confirmed or suspected to be of ischemic origin * Scheduled for VT ablation procedure * LVEF \> or = 20%
Exclusion criteria
* Inadequate AAD washout (amiodarone should be maintained at current dose) * Unstable angina * Active ischemia * Cardiac surgery within prior 2 months * Evidence of infection * Prosthetic mitral or aortic valve or mitral/aortic valvular heart disease requiring surgical intervention * History of embolic event * Myocardial infarction within prior 6 weeks * Enrolled in another study * Recurrent sepsis or otherwise not a candidate for catheterization * Hypercoagulable state or inability to tolerate heparin therapy during procedure * Has had an atriotomy or ventriculotomy within prior 4 months * Life expectancy \< 6 months * Class IV NYHA classification
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events (SAEs) | 30 days |
Countries
United States
Outcome results
None listed