LBBAP Implant with a CSP ICD Lead: Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Primary Safety Endpoint — 3 months post-implant Freedom from CSP ICD Lead-related Serious Adverse Device Effects (SADEs) through 3 months post-implant for subjects in which the CSP ICD Lead implant was attempted
Primary Effectiveness Endpoint 1 — 3-months post-implant 3-month composite success rate of acceptable pacing capture thresholds and R-wave sense amplitudes of the CSP ICD Leads in the subjects with the CSP ICD Lead implanted at the LBBA
Primary Effectiveness Endpoint 2 — at implant Success rate of the defibrillation testing at implant in the subjects who complete the defibrillation test with the CSP ICD Lead implanted at the LBBA
Trial sites (37)
Facility
City
Region
Status
Heart Center Research LLC
Huntsville
Alabama
Banner University Medical Center Phoenix
Phoenix
Arizona
Arrhythmia Research Group
Jonesboro
Arkansas
Premier Cardiology, Inc.
Newport Beach
California
University of California at San Diego (UCSD) Medical Center
San Diego
California
MedStar Washington Hospital Center
Washington D.C.
District of Columbia
AdventHealth Orlando
Orlando
Florida
Beth Israel Deaconess Medical Center
Boston
Massachusetts
New York Presbyterian Hospital/Cornell University
New York
New York
The Cleveland Clinic Foundation
Cleveland
Ohio
Geisinger Medical Center
Danville
Pennsylvania
Lancaster General Hospital
Lancaster
Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia
Pennsylvania
Erlanger Medical Center
Chattanooga
Tennessee
Medical City Dallas Hospital
Dallas
Texas
Sentara Norfolk General Hospital
Norfolk
Virginia
The Prince Charles Hospital
Chermside
Queensland
Princess Alexandra Hospital
Woolloongabba
Queensland
Royal Adelaide Hospital
Adelaide
South Australia
Monash Health
Clayton
Victoria
MUHC- Montreal General Hospital
Montreal
Canada
CHRU Hopital de Pontchaillou
Rennes
Brittan
CHU Trousseau
Chambray-lès-Tours
Centre-Val de Loire
Hôpital Pitié Salpetrière
Paris
Ile
Prince of Wales Hospital
Hong Kong
Hong Kong
Queen Mary Hospital
Hong Kong
Hong Kong
Max Super Specialty Hospital
New Delhi
National Capital Territory of Delhi
Sree Chitra Tirunal Institute for Medical Sciences & tech.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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