Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)

Inclusion Criteria:

- Men and women 18 years of age or older.

- Understand the nature of the procedure.

- Give written informed consent.

- Willing and able to complete all testing required by the clinical protocol.

- Indication for an implantable cardioverter defibrillator (ICD).

- NYHA class III-IV within the last three months prior to enrollment and at baseline (at
baseline only: also Stage C according to ACC/AHA guidelines).

- Stable optimal pharmacologic therapy for HF.

- An ejection fraction ≤ 35% within one year prior to enrollment and confirmed on the
baseline echocardiogram.

- Increased left ventricular dimension, defined as LVEDD ≥ 55 mm.

- Resting QRS duration < 130 ms evidenced by a historical 12-lead ECG prior to
enrollment and at baseline.

- Ventricular dyssynchrony assessed by echocardiography locally and confirmed by the
echo core lab. One of the two following criteria has to be present to include the
subject in the study:

- Intra-left ventricular dyssynchrony measured by color Tissue Doppler Imaging
(TDI) with an opposing wall delay of ≥ 80 ms in the 4-chamber or apical long-axis
view.

- Speckle-tracking radial strain septal-posterior wall delay ≥ 130 ms.

Exclusion Criteria:

- Implanted pacemaker or defibrillator with >10% ventricular pacing, as demonstrated by
device statistics averaged over at least the last three months prior to enrollment.

- Women who are pregnant, lactating, or planning to become pregnant during the course of
the trial.

- Bradycardia pacing indication.

- Surgically correctable primary valvular heart disease, i.e. aortic stenosis, torn
cordae, or flail segment.

- Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon
and/or stent angioplasty) within the past 3 months prior to enrollment.

- Enzyme-positive myocardial infarction within the past 3 months prior to enrollment.

- Angiographic evidence of coronary disease, candidates for coronary revascularization
likely to undergo coronary artery bypass graft surgery or percutaneous coronary
intervention in the next 3 months.

- Irreversible brain damage from preexisting cerebral disease.

- Reversible non-ischemic cardiomyopathy such as acute viral myocarditis.

- Permanent second or third degree heart block.

- Chagas disease.

- Persistent or paroxysmal atrial fibrillation within one month prior to enrollment.

- Expected to receive heart transplantation within six months.

- Current inotropic therapy.

- Acutely decompensated heart failure.

- Contrast dye allergy and unable or unwilling to undergo pretreatment with steroids
and/or diphenhydramine.

- Life expectancy of less than six months.

- Presence of any disease, other than the subject's cardiac disease associated with a
reduced likelihood of survival for the duration of the trial, (e.g. cancer).

- Significant renal insufficiency defined as a serum creatinine > 2.5 mg/dL (> 221
µmol/L) within the last four weeks prior to enrollment..

- Liver failure, defined as three times the upper limit of normal for aminotransferases.

- Participation in any other clinical trial.

- Unable to return for follow-up visits due to distance from the clinic.

- Do not anticipate being a resident of the area for the scheduled duration of the
trial.