Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
- Conditions
- Tachyarrhythmia
- Interventions
- Device: Defibrillation (RV Implant)Device: Defibrillation (LBBAP Implant)
- Registration Number
- NCT04863664
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Brief Summary
The LEADR study is designed to assess the safety and efficacy of the Next Generation ICD lead.
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.
- Detailed Description
The LEADR and LEADR LBBAP studies will enroll subjects who are indicated to receive an implantable single or dual chamber ICD, or CRT-D, and who meet all of the inclusion criteria and none of the exclusion criteria. Subjects will receive an investigational Next Generation ICD Lead. Subjects in the LEADR study will be followed for at least 18 months following Next Generation ICD Lead implantation in a septal (non-LBBAP) or apical implant location. Enrollment in the LEADR study has been completed (675 subjects enrolled). Subjects in the LEADR LBBAP study will be followed for at least 3 months (ICD-indicated subjects) or 6 months (CRT-indicated subjects) following Next Generation ICD Lead implantation in an LBBAP implant location. Enrollment in the LEADR LBBAP study has been completed (323 subjects enrolled).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 998
-
Subject meets current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following:
- 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)
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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.
LEADR
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Subject is unwilling or unable to personally provide Informed Consent.
-
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.
-
Subject with any exclusion criteria as required by local law (e.g., age or other).
-
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
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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
LEADR LBBAP Inclusion Criteria:
-
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
LEADR LBBAP Exclusion Criteria:
-
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
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Subject with previous subcutaneous ICD (S-ICD), extravascular ICD (EV ICD) or Implantable Cardiac Monitor explanted within 30 days before implant
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Subject with any evidence of active bacterial infection or undergoing treatment for a bacterial infection within the last 30 days
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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
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention/Treatment (LEADR) Defibrillation (RV Implant) Patients will be implanted with a Next Generation ICD Lead and undergo required electrical testing Intervention/Treatment (LEADR LBBAP) Defibrillation (LBBAP Implant) Patients will be implanted with a Next Generation ICD Lead in the LBBAP location and undergo required electrical testing
- Primary Outcome Measures
Name Time Method LEADR: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead Day 1 Defibrillation testing will be completed in a subset of subjects at implant.
LEADR: Estimate the rate of major Lead complication-free rate at 6 months Implant to 6 Months Subjects free of Next Generation ICD lead-related complication at 6 months post-implant.
LEADR LBBAP: The lead-related major complication rate at 3-months Implant to 3 Months Subjects free of Next Generation ICD lead-related complication at 3 months post-implant.
LEADR LBBAP: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead Day 1 Defibrillation testing will be completed with the Next Generation ICD Lead in the LBBAP location in a subset of subjects at implant.
- Secondary Outcome Measures
Name Time Method LEADR: Estimate the fracture-free rate of the Next Generation ICD lead up to 24 months Subjects will be assessed at certain time points for Next Generation ICD lead fracture related to the Next Generation ICD lead.
Trial Locations
- Locations (55)
LEADR: Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
LEADR LBBAP: Szpital Uniwersytecki w Krakowie
🇵🇱Kraków, Poland
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: Ashford Hospital
🇦🇺Ashford, South Australia, Australia
LEADR: Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
LEADR: Lourdes Cardiology Services
🇺🇸Voorhees, 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: Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
LEADR LBBAP: Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes Barre, Pennsylvania, 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& 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: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
🇨🇦Québec City, Quebec, Canada
LEADR: Shanxi Cardiovascular Hospital
🇨🇳Taiyuan, Shanxi, China
LEADR & LEADR LBBAP: The Prince Charles Hospital
🇦🇺Chermside, Queensland, 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: 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, 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: Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz Cardiology
🇵🇹Carnaxide, Portugal
LEADR: Klinicki Centar Srbije Pejsmejker centar
🇷🇸Belgrad, Serbia
LEADR: Ng Teng Fong General Hospital
🇸🇬Singapore, Singapore
LEADR & LEADR LBBAP: Imperial College Healthcare NHS Trust - Hammersmith Hospital
🇬🇧London, United Kingdom
LEADR LBBAP: Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
LEADR: Hospital Universitario y Politécnico La Fe
🇪🇸Valencia, Spain
LEADR: Hospital Universitari Bellvitge
🇪🇸L'Hospitalet De Llobregat, Spain