MultiPoint Pacing Programming Guided by Noninvasive Hemodynamics

Noninvasive Hemodynamics for MultiPoint(TM) Pacing Programming in Cardiac Resynchronization Therapy Patients

The purpose of this study is to evaluate noninvasive hemodynamics with MultiPoint™ Pacing (MPP) and biventricular (BiV) pacing under various vector combinations and paced delays in patients receiving cardiac resynchronization therapy (CRT).

Inclusion Criteria:

• Be scheduled to undergo de novo implant of a St. Jude Medical CRT-D system
• Be in NYHA II or III functional class with approved standard indication by ESC/EHRA Guidelines
• Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule

Exclusion Criteria:

• Have persistent or permanent atrial fibrillation
• Have a recent myocardial infarction within 40 days prior to enrollment
• Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 12 months
• Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months prior to enrollment
• Have had intravenous inotropic support in the last 30 days
• Be scheduled or considered for heart transplantation over the next 12 months
• Be less than 18 years of age
• Be pregnant or plan to become pregnant over the next 12 months