Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boston Scientific Corporation
Age
21–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject with a Boston Scientific transvenous ICD (de novo implant or upgrade from pacemaker to ICD) implanted because of one of the following:
* Prior myocardial infarction (MI) and left ventricular ejection fraction (LVEF) ≤ 30% OR
* Ischemic or non-ischemic cardiomyopathy, and LVEF ≤ 35%, and a New York Heart Association (NYHA) class II or III
Subject is age 21 or above, or is considered of legal age per given geography
Subject is willing and capable of providing informed consent
Subject is willing and capable of complying with follow-up visits as defined by this protocol
You may not be if
History of spontaneous sustained Ventricular Tachycardia (VT) (≥ 160 bpm at ≥ 30 seconds in duration) or Ventricular Fibrillation (VF) not due to a reversible cause
NYHA Class IV documented in the medical records within 90 calendar days prior to enrollment
Subject is eligible and scheduled for cardiac resynchronization (CRT) implant
Subjects with a previous subcutaneous ICD (S-ICD)
Subject with existing transvenous ICD (TV-ICD) device implanted for greater than 60 days
Subjects with coronary artery bypass graft surgery or percutaneous coronary intervention within the past 90 calendar days prior to enrollment
Subjects with documented myocardial infarction within the past 90 calendar days prior to enrollment
Subjects on the active heart transplant list
Subject who has a ventricular assist device (VAD) or is to receive a VAD
Life expectancy shorter than 18 months due to any medical condition (e.g., cancer, uremia, liver failure, etc…)
Subjects currently requiring hemodialysis
Subject who is known to pregnant or plans to become pregnant over the course of the trial
Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
