HEAL-HF: A Cardiac Resynchronization Therapy (CRT) Outcomes Study

HEmodynamic Assessment of Optimal Left Heart Lead Placement for Heart Failure Enabled by Magnetic Navigation

The literature shows that approximately 40% of individuals who receive a cardiac resynchronization therapy (CRT) device for symptomatic congestive heart failure (CHF) do not have a clinical benefit from the device. The HEAL-HF protocol will compare the outcomes of conventionally placed CRT devices with magnetically placed CRT devices by assessing hemodynamic parameters during the magnetic placement of the left ventricular (LV) lead.

Baseline information will be obtained including QoL, 6-minute walk, and echo measurements. The patient will be randomized to receive a conventionally-placed LV lead or randomized to receive a magnetically-placed LV lead. The magnetic group will have acute hemodynamics assessed during the procedure to evaluate the best response of the left ventricle during pacing. Patients will be followed for 6 months with a re-evaluation of the baseline tests to assess the change in HF symptoms. Adverse events will also be recorded during the follow-up period.

Inclusion Criteria:

• Ischemic cardiomyopathy
• Ejection Fraction (EF) <= 35%
• QRS duration >= 120 msec
• Standard heart failure (HF) oral medications for at least 1 month
• Evidence of mechanical dyssynchrony
• NYHA Class III or IV

Exclusion Criteria:

• Persistent or chronic atrial fibrillation (AF)
• Hemodynamically unstable or uncontrolled arrhythmias
• Unstable angina
• Aortic valve (AV) insufficiency or stenosis
• Mitral valve (MV) regurgitation > 2+
• Active infection
• Contraindications for heparin
• Dependence on atrial pacing