ASCEND CSP IDE Study

Prior treatment

• Subject has had myocardial infarction or unstable angina within 40 days prior to signing consent
• Subject has had recent cardiac revascularization (angioplasty, stent or bypass graft) in the 4 weeks prior to signing consent or planned within 3 months following consent
• Subject has had any other therapeutic cardiovascular procedure (such as transcatheter aortic valve replacement, MitraClip, cardiac surgery, left atrial appendage closure, patent foramen ovale closure, or any ablation procedures) in the 3 months prior to signing consent or planned within 3 months following consent
• Subject has had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of prior to signing consent
• Subject has ventricular septal defect (VSD) or had prior surgery on the interventricular septum that could impact LBBAP implant, such as septal myomectomy, ethanol septal ablation, VSD repair, etc
• Subject has had previously extracted leads
• Subject has had a failed LBBAP lead implant
  • Defibrillation testing exclusion criteria (these are part of general exclusion criteria when defibrillation testing is requested):
• Subject has pre-existing or suspected pneumothorax during implant

Other illness

• Subject has contraindications for standard RV transvenous and/or LBBAP lead placement (e.g., mechanical right heart valve)
• Subject has an existing pacemaker (including a temporary pacing system), ICD, CRT, or cardiac contractility modulation (CCM) device or leads
• Subject has any evidence of active infection or undergoing treatment for an infection
• Subject has end-stage renal disease
• Subject has undergone cardiac transplantation or have a classification of Status 1 for cardiac transplantation or consideration for transplantation during the study follow-up period
• Subject has severe proximal three-vessel or left main coronary artery disease without revascularization
• Subject has recent stroke or transient ischemic attack (within the last 6 months)
• Subject has any other known medical condition not listed that precludes their participation in the opinion of the investigator

Lab values

• Subject is contraindicated for ≤1mg Dexamethasone sodium phosphate.
• Subject has Ejection Fraction less than 20%

Other

• Subject has a life expectancy of less than 12 months
• Subject is pregnant or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence
• Subject is enrolled or planning to enroll in another clinical trial that might confound the results of the present study
• Subject has moderate or severe aortic stenosis
• Subject has NYHA IV classification
• Subject has had an LV Assist Device
• Subject has current known intracardiac left atrial or Left Ventricular thrombus
• Subject has known inadequate external defibrillation

• Subject must meet current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following:
  • de novo Abbott ICD system implant (single or dual chamber)
  • de novo Abbott CRT-D system implant and is intended to also undergo left ventricle coronary sinus lead implant (for patients indicated for CRT-D according to locally approved indications)
• Subject is ≥ 18 years of age or age of legal consent, whichever age is greater.
• Subject is willing to undergo implant defibrillation testing if requested. Subjects with AF in whom defibrillation testing is required must have been on or willing to be on uninterrupted anticoagulation therapy before, during, and after the implant procedure.
• Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams.
• Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC.