Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
414 participants
INTERVENTIONAL
2025-04-11
2028-05-31
Brief Summary
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The clinical investigation will enroll up to 414 subjects at up to 70 participating centers from the United States, Canada, Europe, and Asia Pacific.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Subjects undergoing ICD/CRT implant will be implanted with the CSP ICD Lead in the LBBAP location and undergo required electrical testing
LBBAP Implant with a CSP ICD Lead
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
Interventions
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LBBAP Implant with a CSP ICD Lead
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
Eligibility Criteria
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Inclusion Criteria
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
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
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
18 Years
99 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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Heart Center Research LLC
Huntsville, Alabama, United States
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Premier Cardiology, Inc.
Newport Beach, California, United States
University of California at San Diego (UCSD) Medical Center
San Diego, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
AdventHealth Orlando
Orlando, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
New York Presbyterian Hospital/Cornell University
New York, New York, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Erlanger Medical Center
Chattanooga, Tennessee, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
The Prince Charles Hospital
Chermside, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
MUHC- Montreal General Hospital
Montreal, , Canada
CHRU Hopital de Pontchaillou
Rennes, Brittan, France
CHU Trousseau
Chambray-lès-Tours, Centre-Val de Loire, France
Hôpital Pitié Salpetrière
Paris, Ile, France
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, India
Sree Chitra Tirunal Institute for Medical Sciences & tech.
Trivandrum, New Delhi, India
Velammal Medical College Hospital
Madurai, Tmlnadu, India
Ospedale S.S. Annunziata
Taranto, Apulia, Italy
Ospedale Niguarda Ca'Granda
Milan, Lombard, Italy
National Heart Centre Singapore
Singapore, Singapore, Singapore
Changi General Hospital
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hopital Cantonal Universitaire de Geneva
Geneva, Canton of Geneva, Switzerland
Countries
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Facility Contacts
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Other Identifiers
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ABT-CIP-10549
Identifier Type: -
Identifier Source: org_study_id
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