Please select the eligibility criteria that correspond to the clinical trial below.
Title: Resynchronization/Defibrillation for Ambulatory Heart Failure Trial
Brief Summary: Congestive heart failure (CHF) is a common health problem that leads to frequent hospitalizations and an increased death rate. In spite of advances in drug therapy, it remains a significant public health problem. Recently, a new therapy has been developed for advanced heart failure patients with a ventricular conduction abnormality. This new therapy, called cardiac resynchronization (CRT), is a device which stimulates the atrium, the right ventricle, and the left ventricle providing synchronization of the contraction of the heart chambers. It is the addition of this therapy to an implantable cardioverter defibrillator (ICD) that will be evaluated in this study. This study will compare whether the implantation of this new therapy device, in combination with an implantable cardioverter defibrillator, will reduce total mortality and hospitalizations for CHF.


Options:
A: Inclusion Criteria:

* Moderate or severe heart failure, defined as symptomatic heart failure for at least six months with NYHA Class III or IV symptoms at the time of enrollment, AND at least one of the following events in the previous 12 months:
* Hospitalization for heart failure management
* Outpatient visit in which intravenous (IV) inotropes or vasoactive infusion were administered continuously for at least 4 hours
* Emergency room visit of at least twelve hours duration in which IV heart failure medications were administered (including diuretics)
* QRS \> or = 120 ms and PR interval \> 150 ms from any two leads of a 12-lead ECG
* Left ventricular ejection fraction \< or = 35%
* Left ventricular end diastolic dimension \> or = 60 mm (required only if LVEF measured by echo) or \> 3.0 cm/m2 \[The cm/m2 is calculated by LVEDD (in cm) divided by BSA (body surface area)\].
* Age \> or = 18 years
* Optimal pharmacologic therapy for heart failure

Exclusion Criteria:

* Unable or unwilling to undergo device implant and follow-up testing
* Meet the general indications for an implantable cardioverter defibrillator
* Meet the general indications for antibradycardia pacing
* Expected to receive a heart transplant in the next six months
* Chronic, medically refractory atrial tachyarrhythmias
* Unexplained syncope
* Myocardial infarction within 60 days of randomization
* History of non-compliance with oral heart failure therapy
* Progressive or unstable angina
* Uncontrolled blood pressure: Systolic BP \> 160 mm Hg or \< 85 mm Hg or diastolic BP \> 90 mm Hg
* Patients with a hypersensitivity to a 0.7 mg nominal dose of dexamethasone acetate
* Surgically uncorrected primary valvular heart disease
* Coronary artery disease (CAD) in which surgical or percutaneous correction is recent (within 60 days of randomization)
* Women who are pregnant or not using medically acceptable birth control
* Hypertrophic obstructive cardiomyopathy
* Amyloid disease
* Hospitalization for heart failure or IV inotropic or vasoactive therapy in excess of 4 hours in the 30 days prior to enrollment
* Have a tricuspid prosthesis
* Involved in any other investigational studies
* Life expectancy \< 6 months due to any other medical conditions
B: Inclusion Criteria:

* Subject has standard class I or class IIa indication for pacemaker implantation in accordance with ACC/AHA/HRS guidelines
* Subjects diagnosed with atrioventricular (AV) block. An AV block is a disturbance when the heart's natural pacemaker sends a message from the atrium (top part of heart) to the ventricle (bottom part of heart) and the message is partially or totally blocked
* Subject is receiving first time implant
* Subjects with heart failure but no symptoms of it (New York Heart Association \[NYHA\] Class I), or subjects with mild heart failure that only sometimes interferes with their daily activities (NYHA Class II), or subjects with heart failure that severely limits daily activities (NYHA Class III)
* Subjects with documented reduced heart pumping function (left ventricular ejection fraction ≤ 50%) within past 90 days
* Subject is at least 18 years old
* Subject or authorized legal guardian or representative has signed and dated the Informed Consent
* Subject is able to receive a pectoral implant
* Subject is expected to remain available for follow-up visits at the study center
* Subject is willing and able to comply with the protocol

Exclusion Criteria:

* Subject has ever had a previous or has an existing device implant
* Subjects with some forms of chest pain or myocardial infarction (heart attack) within the past 30 days
* Subjects with coronary bypass within the past 30 days
* Subjects with stent within the past 30 days
* Subjects with valve repair or replacement within the past 6 months or is indicated for repair or replacement
* Subjects with a mechanical right heart valve
* Subject is indicated for a biventricular pacing device (CRT-P or CRT-D devices)
* Subject is enrolled in a concurrent study which may confound the results of this study (co-enrollment in any concurrent clinical study requires approval of the study manager)
* Subject is pregnant, or of child bearing potential and not on a reliable form of birth control
* Subjects with a previous heart transplant
* Subjects has been classified as NHYA Functional Class IV within prior 90 days (subjects with severe heart failure and should always be resting)
* Subject, legal guardian or authorized representative is unable or unwilling to cooperate or give written informed consent
C: Inclusion Criteria:

* Coronary artery disease or dilated cardiomyopathy with low ejection fraction implanted with an ICD in the setting of primary prevention (criteria at the discretion of the physician)

Exclusion Criteria:

* Setting of secondary prevention
* Other cardiopathies such as congenital, channelopathies, valvulopathies
D: 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

Answer: D