Comparison of Epicardial Versus Conventional Lead Placement in Cardiac Resynchronization Therapy

Randomized Study of Endovascular Versus Epicardial Lead Placement for Resynchronization Therapy

The primary goal of this study is to evaluate the use of robotically -assisted device leads as a primary strategy for heart resynchronization.This trials aims to compare transvenous lead placement with robotic lead placement for cardiac resynchronization therapy.

A secondary goal is to explore the link between efficacy of CRT and inotropic contractile reserve as measured by dobutamine stress echocardiography.

Inclusion Criteria:

• Symptomatic NYHA class III or IV heart failure from idiopathic or ischemic heart failure
• QRS interval greater than or equal to 130 msec
• Left ventricular end diastolic diameter greater than or equal to 55 mm
• left ventricular ejection fraction less than or equal to 35
• Willingness to participate

Exclusion Criteria:

• Acute renal failure; active GI bleeding; unexplained fever which may be due to an infection
• untreated active infection
• acute stroke
• severe uncontrolled systemic hypertension
• severe systemic electrolyte imbalance
• severe concomitant illness that drastically shortens life expectancy
• severe coagulopathy
• history of severe COPD and inability to tolerate single lung ventilation
• History of prior left sided thoracotomy
• history of recent intravenous drug use
• concomitant psychiatric diagnosis that impairs patient's ability to comply with study protocol
• participation in another investigational protocol