Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)

Exclusion Criteria

• •Subject is unwilling or unable to personally provide Informed Consent.
• •Subject has contraindications for standard RV transvenous lead placement (e.g., mechanical right heart valve).
• •Subject is contraindicated for ≤1 mg dexamethasone acetate.
• •Subject has a life expectancy of less than 12 months
• •For subject undergoing defibrillation testing the following medical conditions exclude them:
• •* Pre-existing or suspected pneumothorax during implant
• •* Current intracardiac left atrial or left ventricular (LV) thrombus
• •* Severe aortic stenosis
• •* Severe proximal three-vessel or left main coronary artery disease without revascularization
• •* Unstable angina
• •* Ejection Fraction less than 25%
• •* Recent stroke or transient ischemic attack (within the last 6 months)
• •* Known inadequate external defibrillation
• •* Any other known medical condition not listed that precludes their participation in the opinion of the investigator
• •Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager.
• •Pregnant women or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence
• •Subject with an existing pacemaker (including transcatheter pacing system), ICD, or CRT device or leads
• •Subject with any evidence of active infection or undergoing treatment for an infection
• •Recent (or planned) cardiac surgery or stenting less than 1 month before implant
• •End stage renal disease
• •Subjects with NYHA IV classification
• •Subjects with a transplanted heart
• •Subjects with previously extracted leads
• •Subjects with Left Ventricular Assist Device
• •Subject has contraindication for screw-in active fixation transvenous lead placement (e.g., mechanical right heart valve)
• •Subject is contraindicated for ≤1 mg dexamethasone acetate
• •Subject has a life expectancy of less than 12 months
• •For subject undergoing defibrillation testing the following medical conditions exclude them:
• •* Pre-existing or suspected pneumothorax
• •* Current intracardiac left atrial or LV thrombus
• •* Severe aortic stenosis
• •* Severe proximal three-vessel or left main coronary artery disease without revascularization
• •* Unstable angina
• •* Recent stroke or transient ischemic attack (within the last 6 months)
• •* Known inadequate external defibrillation
• •* Any other known medical condition not listed that precludes their participation in the opinion of the investigator
• •Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
• •Subject is pregnant or breastfeeding, or subject is of childbearing potential and not on a reliable form of birth regulation method or abstinence
• •Subject with an existing pacemaker (including transvenous and transcatheter pacing system), ICD (transvenous) or CRT-D (transvenous) device or leads
• •Subject with previous subcutaneous ICD (S-ICD), extravascular ICD (EV ICD) or Implantable Cardiac Monitor explanted within 30 days before implant
• •Subject with any evidence of active bacterial infection or undergoing treatment for a bacterial infection within the last 30 days
• •Recent (or planned) cardiovascular intervention within 30 days before or after implant, such as cardiac surgery, cardiac ablation, Percutaneous Coronary Intervention (PCI), or temporary cardiac pacing for \>12 hours
• •Subjects with end stage renal disease
• •Subjects with NYHA IV classification
• •Subjects with a transplanted heart or on the waiting list for a heart transplant
• •Subjects with previously extracted leads
• •Subjects with Left Ventricular Assist Device
• •Subjects that are vulnerable adults