Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Tachyarrhythmia
• Intervention / Treatment: Device: Defibrillation (RV Implant); Device: Defibrillation (LBBAP Implant)

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.

• Study Type: Interventional
• Enrollment (Estimated): 975
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Garran, Australia, 2605
    • LEADR: Canberra Hospital
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • LEADR: The Prince Charles Hospital
  • South Australia
    • Ashford, South Australia, Australia, 8032
      • LEADR: Ashford Hospital
    • Norwood, South Australia, Australia, 5000
      • LEADR: Royal Adelaide
• Austria
  • Mitterweg
    • Krems, Mitterweg, Austria, 3500
      • LEADR: Universitätsklinikum Krems
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • LEADR: University of Calgary
  • Ontario
    • Newmarket, Ontario, Canada, L3Y8C3
      • LEADR: Southlake Regional Health Centre
  • Quebec
    • Québec City, Quebec, Canada, G1V 4G5
      • LEADR: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
• China
  • Chengdu, China
    • LEADR: West China Hospital of Sichuan University
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • LEADR: Shanxi Cardiovascular Hospital
• Denmark
  • Copenhagen, Denmark, 2100
    • LEADR: Rigshospitalet
• France
  • La Tronche, France, 38700
    • LEADR: Centre Hospitalier Universitaire de Grenoble - Site Nord
  • Rouen, France, 76031
    • LEADR: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
• Germany
  • Bielefeld, Germany, 33604
    • LEADR: Klinikum Bielefeld Kardiologie
• Hong Kong
  • Hong Kong, Hong Kong
    • LEADR: Queen Mary Hospital
  • Lai Chi Kok, Hong Kong, 999077
    • LEADR: Princess Margaret Hospital
• Italy
  • Bergamo, Italy, 24127
    • LEADR: Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII
• Japan
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 802-8555
      • LEADR: Kokura Memorial Hospital
  • Osaka
    • Suita, Osaka, Japan, 564-8565
      • LEADR: National Cerebral and Cardiovascular Center
  • Tokyo
    • Shinjuku-Ku, Tokyo, Japan, 162-8666
      • LEADR: Tokyo Women's Medical University Hospital
• Malaysia
  • Kuala Lumpur, Malaysia, 50400
    • LEADR: Institut Jantung Negara - National Heart Institute
• Portugal
  • Carnaxide, Portugal, 2790-134
    • LEADR: Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz Cardiology
• Serbia
  • Belgrad, Serbia
    • LEADR: Klinicki Centar Srbije Pejsmejker centar
• Singapore
  • Singapore, Singapore
    • LEADR: Ng Teng Fong General Hospital
• Spain
  • L'Hospitalet De Llobregat, Spain
    • LEADR: Hospital Universitari Bellvitge
  • Valencia, Spain, 46026
    • LEADR: Hospital Universitario y Politécnico La Fe
• United Kingdom
  • London, United Kingdom, W12 0HS
    • LEADR: Imperial College Healthcare NHS Trust - Hammersmith Hospital
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • LEADR: Heart Center Research
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • LEADR: Hartford Hospital
  • Florida
    • Tampa, Florida, United States, 33606
      • LEADR: University of South Florida
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • LEADR: Minneapolis Heart Institute Foundation
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • LEADR: Saint Luke's Mid America Heart Institute
    • Saint Louis, Missouri, United States, 63110
      • LEADR: Washington University School of Medicine
  • New Jersey
    • Voorhees, New Jersey, United States, 08034
      • LEADR: Lourdes Cardiology Services
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • LEADR: Presbyterian Heart Group
  • New York
    • Bay Shore, New York, United States, 11030
      • LEADR: South Shore University Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45202
      • LEADR: TriHealth Hatton Research Institute
    • Cleveland, Ohio, United States, 44195
      • LEADR: Cleveland Clinic
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • LEADR: Lehigh Valley Hospital - Cedar Crest
    • Philadelphia, Pennsylvania, United States, 19104
      • LEADR: Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • LEADR: The Children's Hospital of Philadelphia
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • LEADR: Vanderbilt University medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • LEADR: Texas Cardiac Arrhythmia Research Foundation
    • Fort Worth, Texas, United States, 76104
      • LEADR: Texas Health Fort Worth Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • LEADR: University of Virginia Medical Center
    • Richmond, Virginia, United States, 23298
      • LEADR: Virginia Commonwealth University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

LEADR Inclusion Criteria:

• 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)
• 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 Exclusion Criteria:

• 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
• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention/Treatment (LEADR); Patients will be implanted with a Next Generation ICD Lead and undergo required electrical testing	Device: Defibrillation (RV Implant); Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
Experimental: Intervention/Treatment (LEADR LBBAP); Patients will be implanted with a Next Generation ICD Lead in the LBBAP location and undergo required electrical testing	Device: Defibrillation (LBBAP Implant); Required electrical testing for pacing, sensing, impedance and defibrillation will be completed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LEADR: Estimate the rate of major Lead complication-free rate at 6 months	Subjects free of Next Generation ICD lead-related complication at 6 months post-implant.	Implant to 6 Months
LEADR: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead	Defibrillation testing will be completed in a subset of subjects at implant.	Day 1
LEADR LBBAP: Percentage of subjects successfully defibrillated at implant with the Next Generation ICD lead	Defibrillation testing will be completed with the Next Generation ICD Lead in the LBBAP location in a subset of subjects at implant.	Day 1
LEADR LBBAP: The lead-related major complication rate at 3-months	Subjects free of Next Generation ICD lead-related complication at 3 months post-implant.	Implant to 3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LEADR: Estimate the fracture-free rate of the Next Generation ICD lead	Subjects will be assessed at certain time points for Next Generation ICD lead fracture related to the Next Generation ICD lead.	up to 24 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: George Crossley, MD, Vanderbilt University (LEADR); Principal Investigator: Pugazhendhi Vijayaraman, MD, Geisinger Medical Center (LEADR LBBAP)

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Actual): August 29, 2023
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia
• Other Study ID Numbers: MDT19004 / MDT22048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes