Evaluation of Inducible Monomorphic Ventricular Tachycardia (MMVT) in Patients With St. Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) Systems or Cardiac Resynchronization Therapy Defibrillation (CRT-D) Systems.
Evaluation of Inducible Monomorphic Ventricular Tachycardia (MMVT) in Patients With St. Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) Systems or Cardiac Resynchronization Therapy Defibrillation (CRT-D) Systems.
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.
Inclusion Criteria:

 Patient is receiving a new SJM ICD or CRT-D implant system, which has study required
 programing capabilities and is appropriate for remote monitoring. Patients who have
 received the ICD or CRT-D up to 30 days prior to enrollment are also eligible.

 Patient consents to have a NIPS/EP study.

 Patient has documented Ejection Fraction (EF) < 50% and / or Right Ventricular (RV)
 dysfunction.

 Patient has documented structural cardiomyopathy of any kind >1 month.

 Patient is between 18 to 75 years of age.

 Patient has been informed of the nature of the study and has agreed to its provisions and
 provided written informed consent using a form approved by the Institutional Review
 Board/Ethics Committee (IRB/EC).

 Exclusion Criteria:

 Patient has history of stroke.

 Patient has had ST Segment elevation myocardial infarction (MI); or previous cardiac
 surgery within 60 days prior to enrollment.

 Patient is pregnant or nursing.

 Patient has chronic New York Heart Association (NYHA) Class IV heart failure.

 Patient has limited life expectancy according to the investigator (less than one year).

 Patient has had a recent coronary artery bypass graft (CABG) (< 60 days) or percutaneous
 coronary intervention (PCI) (< 30 days).

 Patient is currently participating in an investigational drug or device study Patient is
 unable or unwilling to cooperate with the study procedures.

 Patient has a prosthetic mitral or aortic valve.

 Patient has mitral or aortic valvular heart disease requiring immediate surgical
 intervention.

 Patient has Left Ventricular EF < 15%.

 Patient has had a previous ablation procedure for ventricular tachycardia (VT), excluding
 remote (> 3 months) outflow tract tachycardia.

 Patient has previously documented history of severe loss of kidney function or kidney
 failure.

 Patient has premature ventricular contractions (PVC) or VT induced cardiomyopathy expected
 to resolve with ablation and will not require an ICD.

 Patient has reversible cause of VT.