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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment 		Subjects undergoing ICD/CRT implant will be implanted with the CSP ICD Lead in the LBBAP location and undergo required electrical testing
  • Device: LBBAP Implant with a CSP ICD Lead
    Required electrical testing for pacing, sensing, impedance and defibrillation will be completed

Recruiting Locations

Heart Center Research LLC
Huntsville 4068590, Alabama 4829764 35801
Contact:
Michael Kaufmann, MD
256-519-8472
Mkaufmann@theheartcenter.md

Banner University Medical Center Phoenix
Phoenix 5308655, Arizona 5551752 85006
Contact:
Roderick Tung, MD
(602) 839-2000
rodericktung@arizona.edu

Arrhythmia Research Group
Jonesboro 4116834, Arkansas 4099753 72401
Contact:
Devi Nair, MD
917-774-8369
Drdevignair@gmail.com

Premier Cardiology, Inc.
Newport Beach 5376890, California 5332921 92663
Contact:
Rajesh Banker, MD
949-478-7373
rajesh.banker@gmail.com

University of California at San Diego (UCSD) Medical Center
San Diego 5391811, California 5332921 92103
Contact:
Ulrika Birgersdotter-Green, MD
858-657-7000
ubgreen@health.ucsd.edu

MedStar Washington Hospital Center
Washington D.C. 4140963, District of Columbia 4138106 20010
Contact:
Athanasios Thomaides, MD
(202) 877-7000
Athanasios.X.Thomaides@medstar.net

Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
Contact:
Peter Zimetbaum, MD
617-667-7000
pzimetba@BIDMC.Harvard.edu

New York Presbyterian Hospital/Cornell University
New York 5128581, New York 5128638 10021
Contact:
Jim Cheung, MD
212-746-2158
jac9029@med.cornell.edu

The Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44195
Contact:
Niraj Varma, MD
(216) 444-2200
varman@ccf.org

Geisinger Medical Center
Danville 5186327, Pennsylvania 6254927 17822
Contact:
Pugazhendhi Vijayaraman, MD
(570) 271-6211
pvijayaraman1@geisinger.edu

Lancaster General Hospital
Lancaster 5197079, Pennsylvania 6254927 17602
Contact:
Matthew Bernabei, MD
(717) 544-5511
Matthew.Bernabei@pennmedicine.upenn.edu

Hospital of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Robert Schaller, MD
215-349-8027
robert.schaller@uphs.upenn.edu

Erlanger Medical Center
Chattanooga 4612862, Tennessee 4662168 37403
Contact:
Alvaro M Garcia, MD
423-778-8409
alvaro.manriquegarcia@erlanger.org

Sentara Norfolk General Hospital
Norfolk 4776222, Virginia 6254928 23507
Contact:
Divyang Patel, MD
(757) 388-3000
DRPATEL1@sentara.com

More Details

Status
Recruiting
Sponsor
Abbott Medical Devices

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.