Phase
Condition
Heart Defect
Fast Heart Rate (Tachycardia)
Heart Disease
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Patient is receiving a new SJM ICD or CRT-D implant system, which has study requiredprograming capabilities and is appropriate for remote monitoring. Patients who havereceived 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 andprovided written informed consent using a form approved by the Institutional ReviewBoard/Ethics Committee (IRB/EC).
Exclusion
Exclusion Criteria: Patient has history of stroke. Patient has had ST Segment elevation myocardial infarction (MI); or previous cardiacsurgery 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 percutaneouscoronary intervention (PCI) (< 30 days). Patient is currently participating in an investigational drug or device study Patient isunable 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 surgicalintervention. Patient has Left Ventricular EF < 15%. Patient has had a previous ablation procedure for ventricular tachycardia (VT), excludingremote (> 3 months) outflow tract tachycardia. Patient has previously documented history of severe loss of kidney function or kidneyfailure. Patient has premature ventricular contractions (PVC) or VT induced cardiomyopathy expectedto resolve with ablation and will not require an ICD. Patient has reversible cause of VT.