POsition of Leads in Advanced heaRt Failure: the POLAR Study - A 6 Month, Observational, Mult-centered, Blinded, Randomized Study to Determine if Lead Positioning in the Lateral Wall of LV in Patients Meeting Criteria for CRT Plays a Role in Determining Myocardial Function and Affect the Severity of Mitral Regurgitation
The primary objective is to determine if lead positioning in the lateral wall of the left ventricle in patients meeting criteria for cardiac resynchronization therapy plays a role in determining myocardial function and affects the severity of mitral regurgitation.
• Subject meets the general indications for an implantable cardioverter defibrillator (ICD) with LV systolic function ≤ 35% as defined by echocardiography.
• Subject has moderate or severe heart failure, defined as NYHA Class III-IV for at least 90 days prior to enrollment.
• Subject has optimal pharmacological heart failure therapy for at least 30 days prior to enrollment.
• Subject has a 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a sinus rate > 50 bpm and PR interval < 320 ms measured from any two leads.
• 12 lead ECG with left bundle brunch block morphology and a QRS duration of at least 120 msec.
• Subject has creatinine < 2.5 mg/dL obtained no more than 30 days prior to enrollment.
• Subject has left ventricular ejection fraction < 35% by echocardiogram no more than 1 year prior to enrollment.
• Subject is willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation.
• Subject has a life expectancy of more than 180 days, per physician discretion.
• Subject is age 18 or above, or of legal age to give informed consent specific to state and national law.