Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective Randomized Evaluation of an Ultra Conservative Approach to Implantable Defibrillator (ICD) Programming in Patients With a Left Ventricular Assist Device (LVAD).
Brief Summary: We propose to study a strategy empirically applied for the past 6 months at a high volume LVAD center (Vanderbilt Heart and Vascular Institute). This utilizes an ultra conservative device programming strategy to maximize battery longevity, avoid inappropriate implantable cardioverter defibrillator (ICD) therapy, improve quality of life through reduction in overall shock burden, and potentially avoid unnecessary device generator changes prior to transplant. Avoiding CIED (cardiac implantable electronic device) change out device procedures prior to transplant is desirable.


Options:
A: Inclusion:

* Age ≥ 18
* Advanced Heart Failure
* Scheduled for Heartmate II LVAD implant
* With existing ICD

Exclusion:

-Age \< 18
B: Inclusion Criteria:

* 18 years of age or older
* Primary or secondary diagnosis of heart failure or prior myocardial infarction (heart attack)
* Moderate-to-severe left ventricular dysfunction (LVD) as demonstrated by an ejection fraction \< or = 35% and/or a qualitative assessment of LVD of moderate-to-severe or severe LVD
* Patient has been seen at the clinic at least twice in the past 2 years
* Patient received care from the physician participating in the study

Exclusion Criteria:

* Patient has died
* Patient is not expected to survive for 12 months due to medical conditions other than heart failure
* Patient has undergone heart transplant surgery
C: Inclusion Criteria:

* New York Heart Association (NYHA) Class II
* Left ventricular ejection fraction (LVEF) less than or equal to 30% by multigated acquisition scan (MUGA)/catheterization OR LVEF less than or equal to 30% and LV end diastolic dimension ≥ 60 mm (by echocardiogram) within 6 months prior to randomization
* Intrinsic QRS complex width ≥ 120 ms OR paced QRS measurement ≥ 200 ms
* ICD indication for primary or secondary prevention
* Optimal heart failure pharmacological therapy
* Normal sinus rhythm; OR chronic persistent atrial tachyarrhythmia with resting ventricular heart rate ≤ 60 beats per minute (bpm) and 6 minute hall walk ventricular heart rate of ≤ 90 bpm; OR chronic persistent atrial tachyarrhythmia with resting ventricular heart rate \> 60 bpm and 6 minute hall walk ventricular heart rate of \> 90 bpm and booked for atrioventricular junction ablation.

Exclusion Criteria:

* Intravenous inotropic agent in the last 4 days
* Patients with a life expectancy of less than one year from non-cardiac cause
* Expected to undergo cardiac transplantation within one year (status I)
* In hospital patients who have acute cardiac or non-cardiac illness that requires intensive care
* Uncorrected or uncorrectable primary valvular disease
* Restrictive, hypertrophic, or reversible form of cardiomyopathy
* Severe primary pulmonary disease such as cor pulmonale
* Tricuspid prosthetic valve
* Patients with an existing ICD (patients with an existing pacemaker may be included if the patients satisfy all other inclusion/exclusion criteria)
* Coronary revascularization (coronary artery bypass graft surgery \[CABG\] or percutaneous coronary intervention \[PCI\]) \< 1 month if previously determined LVEF \> 30%. Patients with a more recent revascularization can be included if a previously determined LVEF was ≤ 30%.
* Patients with an acute coronary syndrome including myocardial infarction (MI) can be included if the patients have had a previous MI with LV dysfunction (LVEF ≤ 30%).
* Patients included in another clinical trial that will affect the objectives of this study
* History of noncompliance to medical therapy
* Unable or unwilling to provide informed consent
D: Inclusion Criteria:

1. Evidence of Coronary Artery Disease (CAD) a or documented prior Myocardial Infarction.
2. LVEF \>35% by any current standard evaluation technique (e.g.,) echocardiogram, MUGA, angiography). 2.1. Patients who have an LVEF between 30-35% and NYHA Class I heart failure who do not have history of ventricular tachyarrhythmias,or inducible ventricular tachycardia during electrophysiological (EP) testing can be enrolled.
3. If documented prior MI is not present, evidence of mild-moderate systolic Left Ventricular Dysfunction with an EF \>35- ≤50% as measured by any current standard screening technique (e.g.,echocardiogram, MUGA, angiography) must be present.
4. Patients aged 18 years or above

   1. CAD will be defined as evidence of one of the following two (2) criteria:

      * Significant stenosis of a major epicardial vessel (\>50% proximal or 70% distal) by coronary angiography
      * Prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery)
   2. MI can be documented in the following ways:

      * From the MI hospitalization: Detection of a rise and fall of cardiac biomarkers \> 99th percentile of lab (e.g., CPK elevation or Troponin at least \> two times the upper limit of normal) together with myocardial ischemia with at least one of the following:

        * Symptoms of Ischemia
        * ECG changes indicative of new ischemia (new ST-T changes or new LBBB)
        * Development of pathological Q waves
        * Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
      * If no report from the MI hospitalization is available, prior MI can be met by either of the following:

        * Development of pathological Q waves
        * Imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischaemic cause

Exclusion Criteria:

1. History of cardiac arrest or spontaneous or inducible sustained VT (15 beats or more at a rate of 120 BPM or greater - the occurrence of cardiac arrest or spontaneous VT in the setting of an acute MI is not considered an exclusion).
2. Unexplained syncope
3. Current or planned implantable cardiac defibrillator (ICD)
4. Any condition other than cardiac disease that, in the investigator's judgment, would seriously limit life expectancy (poor survival)
5. Metastatic cancer
6. Marked valvular heart disease requiring surgical intervention
7. Current or planned cardiac, renal or liver transplant
8. Current alcohol or drug abuse
9. Unwilling or unable to provide informed consent
10. LVEF \<35% with Class II-IV CHF or LVEF \<30%
11. Participation in a clinical trial where the active treatment arm is testing an agent and/or intervention with known antiarrhythmic properties

Answer: A