ASCEND CSP IDE Study (NCT06830746) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
ASCEND CSP IDE Study
United States414 participantsStarted 2025-04-11
Plain-language summary
This is a prospective, multi-center, global, single-arm, pivotal investigational study designed to evaluate the safety and effectiveness of the CSP ICD Lead in a subject population indicated for ICD or CRT-D therapy.
The clinical investigation will enroll up to 414 subjects at up to 70 participating centers from the United States, Canada, Europe, and Asia Pacific.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. 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.
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 (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 a life expectancy of less than 12 months
✕. Subject has contraindications for standard RV transvenous and/or LBBAP lead placement (e.g., mechanical right heart valve)
✕. Subject is contraindicated for ≤1mg Dexamethasone sodium phosphate.
✕. 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