Left Ventricular MultiSpot Pacing for CRT (iSPOT)

Left Ventricular MultiSpot Pacing for CRT (iSPOT)

The purpose of the iSPOT Study is to evaluate the contractility using positive left ventricular (LV) dP/dt max across LV pacing site(s) in patients indicated for cardiac resynchronization therapy (CRT).

Inclusion Criteria:

• Subject is indicated for cardiac CRT or CRT-D device according to current applicable European Society of Cardiology (ESC)/American Heart Association (AHA) guidelines
• Subject has a left bundle branch block (LBBB) conduction pattern
• Subject is in stable sinus rhythm at the time of implant (no atrial arrhythmias lasting > 30 seconds during the last 2 weeks prior to inclusion and no documented atrial fibrillation (AF) episodes allowed during the last 2 weeks prior to inclusion)
• Subject receives optimal heart failure oral medical therapy (ACE inhibitor and/or angiotensin receptor blockers (ARB) and Beta Blockers), and is on a stable medication scheme for at least 1 month prior to enrollment
• Subject (or the legal guardian) is willing to sign informed consent form
• Subject is 18 years or older or as specified minimal age per local law/regulation

Exclusion Criteria:

• Subject has permanent atrial fibrillation/ flutter or tachycardia
• Subject experienced recent myocardial infarction (MI), within 40 days prior to enrollment
• Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days prior to enrollment
• Subject is post heart transplantation, or is actively listed on the transplantation list
• Subject is implanted with a left ventricular assist device (LVAD)
• Subject is on chronic renal dialysis
• Subject has severe renal disease (defined as estimated Glomerular Filtration Rate (equation provided by Modification of Diet in Renal Disease study): (eGFR) < 30 mL/min/1.73m2)
• Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions per week)
• Subject has severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated within study period)
• Subject has complex and uncorrected congenital heart disease
• Subject has a mechanical heart valve
• Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
• Subject is enrolled in one or more concurrent studies that would confound the results of this study
• Subject is already implanted with a device