IRB Study Number 25-618
Status Recruiting
Institute Heart and Vascular Institute
Description
You may be invited to take part in this research study if you need an ICD (Intracardiac Defibrillator) or a CRT-D (Cardiac Resynchronization Therapy-Defibrillator). The purpose of this study is to study if the CSP ICD Lead is safe and effective in treating adults with heart conditions who need an implantable cardioverter defibrillator (ICD or CRT-D) system.
The CSP (Conduction System Pacing) ICD Lead is an investigational (experimental) device that works by letting signals travel between your heart and the device (ICD or CRT-D), helping the device monitor and treat your heart condition. It is not approved by the Food and Drug Administration (FDA).
You would be asked to return to clinic visits approximately every 6 months to have a 12-lead EKG, complete quality of life questionnaires, have your device checked and device data collected.
Your participation in the research would last about 12 to 18 months.
Inclusion Criteria
- Subject must meet current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following: a. de novo Abbott ICD system implant (single or dual chamber) b. de novo Abbott CRT-D system implant and is intended to also undergo left ventricle coronary sinus lead implant
- Subject is ≥ 18 years of age
- 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
Exclusion Criteria
- 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 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 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 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 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 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 end‐stage renal disease
- Subject has NYHA IV classification
- 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 had previously extracted leads
- Subject has had an LV Assist Device
