Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
NCT ID: NCT04863664
Last Updated: 2025-12-09
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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COMPLETED
NA
998 participants
INTERVENTIONAL
2021-06-21
2025-11-06
Brief Summary
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The LEADR LBBAP study is being conducted under the existing US FDA Investigational Device Exemption (IDE) for the Next Generation ICD Lead and is designed to confirm the safety and defibrillation efficacy of the Next Generation ICD Lead when placed in the LBBAP location in ICD and LOT-CRT patient population.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention/Treatment (LEADR)
Patients will be implanted with a Next Generation ICD Lead and undergo required electrical testing
Defibrillation (RV Implant)
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
Intervention/Treatment (LEADR LBBAP)
Patients will be implanted with a Next Generation ICD Lead in the LBBAP location and undergo required electrical testing
Defibrillation (LBBAP Implant)
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
Interventions
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Defibrillation (RV Implant)
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
Defibrillation (LBBAP Implant)
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
Eligibility Criteria
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Inclusion Criteria
* de novo Medtronic CRT-D system implant
* de novo Medtronic ICD system implant (single or dual chamber)
* Subject has, per local law and requirements, the minimum age for autonomously signing an ICF (minimum age of 18 years)
* Subject is willing to undergo implant defibrillation testing if requested.
* Subject is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up.
* Subject meets current local clinical practice guidelines for implantation of ICD (single or dual chamber) or CRT-D system and will undergo one of the following:
a) De novo Medtronic ICD system implant (single or dual chamber) or b) De novo Medtronic CRT-D system implant and is intended to also undergo LV lead implant (for patients indicated for CRT-D according to locally approved indications/indications)
* Subject is 12 years of age or older and also is greater than 30 kg in weight at time of enrollment, has cardiac anatomy conducive to RV coil placement, and is allowed to participate in study per local law and requirements. Subjects from 12 years of age until adult also have a separate indication for pacing or CRT or are anticipated to develop one.
* Subject provides written authorization and/or consent per institution and geographical requirements.
* Subject is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up
* Subject is willing to undergo implant defibrillation testing if requested
Exclusion Criteria
* Subject has contraindications for standard RV transvenous lead placement (e.g., mechanical right heart valve).
* Subject is contraindicated for ≤1 mg dexamethasone acetate.
* Subject has a life expectancy of less than 12 months
* For subject undergoing defibrillation testing the following medical conditions exclude them:
* Pre-existing or suspected pneumothorax during implant
* Current intracardiac left atrial or left ventricular (LV) thrombus
* Severe aortic stenosis
* Severe proximal three-vessel or left main coronary artery disease without revascularization
* Unstable angina
* Ejection Fraction less than 25%
* Recent stroke or transient ischemic attack (within the last 6 months)
* Known inadequate external defibrillation
* Any other known medical condition not listed that precludes their participation in the opinion of the investigator
* Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager.
* Pregnant women or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence
* Subject with an existing pacemaker (including transcatheter pacing system), ICD, or CRT device or leads
* Subject with any evidence of active infection or undergoing treatment for an infection
* Recent (or planned) cardiac surgery or stenting less than 1 month before implant
* End stage renal disease
* Subjects with NYHA IV classification
* Subjects with a transplanted heart
* Subjects with previously extracted leads
* Subjects with Left Ventricular Assist Device
* Subject has contraindication for screw-in active fixation transvenous lead placement (e.g., mechanical right heart valve)
* Subject is contraindicated for ≤1 mg dexamethasone acetate
* Subject has a life expectancy of less than 12 months
* For subject undergoing defibrillation testing the following medical conditions exclude them:
* Pre-existing or suspected pneumothorax
* Current intracardiac left atrial or LV thrombus
* Severe aortic stenosis
* Severe proximal three-vessel or left main coronary artery disease without revascularization
* Unstable angina
* Recent stroke or transient ischemic attack (within the last 6 months)
* Known inadequate external defibrillation
* Any other known medical condition not listed that precludes their participation in the opinion of the investigator
* Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
* Subject is pregnant or breastfeeding, or subject is of childbearing potential and not on a reliable form of birth regulation method or abstinence
* Subject with an existing pacemaker (including transvenous and transcatheter pacing system), ICD (transvenous) or CRT-D (transvenous) device or leads
* Subject with previous subcutaneous ICD (S-ICD), extravascular ICD (EV ICD) or Implantable Cardiac Monitor explanted within 30 days before implant
* Subject with any evidence of active bacterial infection or undergoing treatment for a bacterial infection within the last 30 days
* Recent (or planned) cardiovascular intervention within 30 days before or after implant, such as cardiac surgery, cardiac ablation, Percutaneous Coronary Intervention (PCI), or temporary cardiac pacing for \>12 hours
* Subjects with end stage renal disease
* Subjects with NYHA IV classification
* Subjects with a transplanted heart or on the waiting list for a heart transplant
* Subjects with previously extracted leads
* Subjects with Left Ventricular Assist Device
* Subjects that are vulnerable adults
12 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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George Crossley, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University (LEADR)
Pugazhendhi Vijayaraman, MD
Role: PRINCIPAL_INVESTIGATOR
Geisinger Medical Center (LEADR LBBAP)
Locations
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LEADR: Heart Center Research
Huntsville, Alabama, United States
LEADR LBBAP: Torrance Memorial Medical Center
Torrance, California, United States
LEADR: Hartford Hospital
Hartford, Connecticut, United States
LEADR: University of South Florida
Tampa, Florida, United States
LEADR & LEADR LBBAP: Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
LEADR: Saint Luke's Mid America Heart Institute
Kansas City, Missouri, United States
LEADR: Washington University School of Medicine
St Louis, Missouri, United States
LEADR: Lourdes Cardiology Services
Voorhees Township, New Jersey, United States
LEADR: Presbyterian Heart Group
Albuquerque, New Mexico, United States
LEADR & LEADR LBBAP: South Shore University Hospital/Northwell Health
Bay Shore, New York, United States
LEADR: TriHealth Hatton Research Institute
Cincinnati, Ohio, United States
LEADR LBBAP: The Christ Hospital
Cincinnati, Ohio, United States
LEADR: Cleveland Clinic
Cleveland, Ohio, United States
LEADR LBBAP: The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
LEADR: Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States
LEADR: Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
LEADR LBBAP: Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
LEADR& LEADR LBBAP: Vanderbilt University medical Center
Nashville, Tennessee, United States
LEADR: Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
LEADR: Texas Health Fort Worth Hospital
Fort Worth, Texas, United States
LEADR & LEADR LBBAP: University of Virginia Medical Center
Charlottesville, Virginia, United States
LEADR & LEADR LBBAP: Virginia Commonwealth University Health System
Richmond, Virginia, United States
LEADR LBBAP: Aurora St. Luke's Hospital
Milwaukee, Wisconsin, United States
LEADR & LEADR LBBAP: The Prince Charles Hospital
Chermside, Queensland, Australia
LEADR: Ashford Hospital
Ashford, South Australia, Australia
LEADR & LEADR LBBAP: Royal Adelaide
Norwood, South Australia, Australia
LEADR &LEADR LBBAP: Canberra Hospital
Garran, , Australia
LEADR: Universitätsklinikum Krems
Krems, Mitterweg, Austria
LEADR LBBAP: Universitair Ziekenhuis Antwerpen
Edegem, Antwerp, Belgium
LEADR: University of Calgary
Calgary, Alberta, Canada
LEADR: Southlake Regional Health Centre
Newmarket, Ontario, Canada
LEADR & LEADR LBBAP: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, Canada
LEADR: Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
LEADR & LEADR LBBAP: West China Hospital of Sichuan University
Chengdu, , China
LEADR: Rigshospitalet
Copenhagen, , Denmark
LEADR: Centre Hospitalier Universitaire de Grenoble - Site Nord
La Tronche, , France
LEADR LBBAP: OC Santé - Clinique du Millénaire
Montpellier, , France
LEADR: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
Rouen, , France
LEADR: Klinikum Bielefeld Kardiologie
Bielefeld, Bielefeld, Germany
LEADR & LEADR LBBAP: Queen Mary Hospital
Hong Kong, , Hong Kong
LEADR: Princess Margaret Hospital
Lai Chi Kok, , Hong Kong
LEADR: Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII
Bergamo, , Italy
LEADR & LEADR LBBAP: Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
LEADR & LEADR LBBAP: National Cerebral and Cardiovascular Center
Suita, Osaka, Japan
LEADR: Tokyo Women's Medical University Hospital
Shinjuku-Ku, Tokyo, Japan
LEADR & LEADR LBBAP: Institut Jantung Negara - National Heart Institute
Kuala Lumpur, , Malaysia
LEADR LBBAP: Maastricht Universitair Medisch Centrum
Maastricht, Limburg, Netherlands
LEADR LBBAP: Szpital Uniwersytecki w Krakowie
Krakow, , Poland
LEADR: Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz Cardiology
Carnaxide, , Portugal
LEADR: Klinicki Centar Srbije Pejsmejker centar
Belgrade, , Serbia
LEADR: Ng Teng Fong General Hospital
Singapore, Singapore, Singapore
LEADR LBBAP: Hospital Universitario Virgen de las Nieves
Granada, Granada, Spain
LEADR: Hospital Universitari Bellvitge
L'Hospitalet de Llobregat, , Spain
LEADR: Hospital Universitario y Politécnico La Fe
Valencia, , Spain
LEADR & LEADR LBBAP: Imperial College Healthcare NHS Trust - Hammersmith Hospital
London, , United Kingdom
Countries
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References
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Crossley GH 3rd, Mason PK, Hansky B, De Filippo P, Shah MJ, Philippon F, Sholevar D, Richardson TD, West MB, Dinerman J, Dawson J, Himes A, Severseike L, Thompson AE, Sanders P. High predicted durability for the novel small-diameter OmniaSecure defibrillation lead. Heart Rhythm. 2025 Feb;22(2):302-310. doi: 10.1016/j.hrthm.2024.09.005. Epub 2024 Sep 26.
Other Identifiers
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MDT19004 / MDT22048
Identifier Type: -
Identifier Source: org_study_id
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