Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT02584595
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02584595
Study Brief:
Protocol Section:
NCT02584595