ASCEND CSP IDE Study (NCT06830746) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
ASCEND CSP IDE Study
United States, Australia, Canada414 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 range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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