Conduction System Pacing Optimized Therapy

Conduction System Pacing Optimized Therapy Study

The purpose of the CSPOT study is to determine the best mode of cardiac resynchronization therapy (CRT) pacing for different populations of CRT patients, comparing traditional biventricular or left ventricular pacing (BiV), conduction system pacing (CSP)-only, and conduction system pacing optimized therapy (CSPOT) also known as a combination of conduction system pacing (CSP) and left ventricular (LV) pacing. Additionally, safety of the system will be assessed.

Inclusion Criteria:

• Patient is willing and able to provide written informed consent
• Subject is at least 18 years of age
• Patient is willing and able to comply with the protocol, including follow-up visits
• The patient's medical records must be accessible by the enrolling site over the follow-up period
• Standard CRT-D or CRT-P indications, with a preference for IVCD and non-LBBB patients, where LBBB is defined according to Strauss criteria.
• De-novo CRT implant, including upgrade from pacemaker or ICD

Exclusion Criteria:

• Subject has persistent or permanent AF (Atrial Fibrillation)/AFL (Atrial Flutter)
• Subject has 2nd or 3rd degree AV (Atrioventricular) Block
• Subject has RBBB with no additional conduction block
• Subject has intrinsic (non-paced) QRS width less than or equal to 120 ms
• Subject experienced MI within 40 days prior to enrollment
• Subject underwent 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 LV assist device
• Subject has severe renal disease
• Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure
• Subject has severe aortic stenosis (with a valve area of <1.0 cm or significant valve disease expected to be operated within study period)
• Subject has severe aortic calcification or severe peripheral arterial disease
• Subject has complex and uncorrected congenital heart disease
• Subject has mechanical heart valve
• Pregnant or breastfeeding woman (pregnancy test required for woman of child-bearing potential and who are not on a reliable form of birth regulation method or abstinence)
• Subject is enrolled in another study that could confound the results of this study without documented pre-approval from Medtronic study manager