The intent of this observational study is to understand the role of non-invasive programmed stimulation (NIPS) to induce substrate based MMVT (Monomorphic Ventricular Tachycardia) in patients receiving new St. Jude Medical Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillation (CRT-D) systems.
Approximately 50 centers worldwide will participate in the study. Additional centers outside the US may be considered, as necessary. The anticipated enrollment duration is 48-60 months. This study provides a mechanism for sites to refer subjects for potential enrollment to the Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT) Investigational Device Exemption (IDE) study (ClinicalTrials.gov NCT02130765). Patients receiving ICD or CRT-D device implant (or have received it within 30 days) may be enrolled in the study.
Study Type
OBSERVATIONAL
ICD/CRT-D implanted patients are tested for inducible MMVT during electrophysiology (EP) Study or Non-Invasive Programmed Stimulation (NIPS) Study
Rate of ICD/CRT-D implanted patients with documented monomorphic ventricular tachycardia.
Time frame: 12 months
Number of ICD shocks.
Time frame: 12 months
Quality of Life via Short Form Survey (SF-36)
Time frame: 12 months
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