Evaluating a new lead for heart devices in patients with heart failure and arrhythmia
A Stylet-Driven ICD Lead Intended for Conduction System Pacing IDE Study
This study is testing a new heart device lead to see if it is safe and effective for people with heart failure and arrhythmia who need an implantable defibrillator.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 414 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Abbott Medical Devices Industry-sponsored |
| Locations | 8 sites (Chermside, Queensland and 7 other locations) |
| Trial ID | NCT06830746 on ClinicalTrials.gov |
What this trial studies
This clinical investigation is a global, multi-center, single-arm study aimed at assessing the safety and effectiveness of the Conduction System Pacing (CSP) ICD Lead in patients who require an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D). The study plans to enroll up to 414 participants across 70 centers in the United States, Canada, Europe, and Asia Pacific. Eligible subjects will undergo implantation of the CSP ICD Lead as part of their treatment for heart failure or ventricular arrhythmia.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who meet the clinical guidelines for ICD or CRT-D implantation.
Not a fit: Patients who do not require an ICD or CRT-D or those who are not suitable for defibrillation testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with heart failure and ventricular arrhythmias.
How similar studies have performed: Other studies have shown promise with similar pacing approaches, but this specific investigation is pivotal and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subject must meet current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following: 1. de novo Abbott ICD system implant (single or dual chamber) 2. 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) 2. Subject is ≥ 18 years of age or age of legal consent, whichever age is greater. 3. 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. 4. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams. 5. 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: 1. Subject has had myocardial infarction or unstable angina within 40 days prior to signing consent 2. 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 3. 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 4. Subject has had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of prior to signing consent 5. Subject has a life expectancy of less than 12 months 6. Subject has contraindications for standard RV transvenous and/or LBBAP lead placement (e.g., mechanical right heart valve) 7. Subject is contraindicated for ≤1mg Dexamethasone sodium phosphate. 8. 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 9. Subject has an existing pacemaker (including a temporary pacing system), ICD, CRT, or cardiac contractility modulation (CCM) device or leads 10. Subject has any evidence of active infection or undergoing treatment for an infection 11. Subject is enrolled or planning to enroll in another clinical trial that might confound the results of the present study 12. Subject has moderate or severe aortic stenosis 13. 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 14. Subject has end-stage renal disease 15. Subject has NYHA IV classification 16. 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 17. Subject has had previously extracted leads 18. Subject has had an LV Assist Device 19. Subject has had a failed LBBAP lead implant Defibrillation testing exclusion criteria (these are part of general exclusion criteria when defibrillation testing is requested): 1. Subject has pre-existing or suspected pneumothorax during implant 2. Subject has current known intracardiac left atrial or Left Ventricular thrombus 3. Subject has severe proximal three-vessel or left main coronary artery disease without revascularization 4. Subject has Ejection Fraction less than 20% 5. Subject has recent stroke or transient ischemic attack (within the last 6 months) 6. Subject has known inadequate external defibrillation 7. Subject has any other known medical condition not listed that precludes their participation in the opinion of the investigator
Where this trial is running
Chermside, Queensland and 7 other locations
- The Prince Charles Hospital — Chermside, Queensland, Australia (Recruiting)
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (Recruiting)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
- Monash Health — Clayton, Victoria, Australia (Recruiting)
- Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
- Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
- Changi General Hospital — Singapore, Singapore (Recruiting)
- Tan Tock Seng Hospital — Singapore, Singapore (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.