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

NCT04863664 | Completed DMC FDA Device

• 1 other identifier: MDT19004 / MDT22048
• Study Type: interventional
• Target: 998
• Locations: 19 countries
• Sites: 51

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.

Conditions

Tachyarrhythmia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• LEADR: Estimate the fracture-free rate of the Next Generation ICD lead

  up to 24 months

Study Arms (2)

Intervention/Treatment (LEADR)

EXPERIMENTAL

Patients will be implanted with a Next Generation ICD Lead and undergo required electrical testing

Device: Defibrillation (RV Implant)

Intervention/Treatment (LEADR LBBAP)

EXPERIMENTAL

Patients will be implanted with a Next Generation ICD Lead in the LBBAP location and undergo required electrical testing

Device: Defibrillation (LBBAP Implant)

Interventions

Defibrillation (LBBAP Implant) DEVICE

Required electrical testing for pacing, sensing, impedance and defibrillation will be completed

Intervention/Treatment (LEADR LBBAP)

Defibrillation (RV Implant) DEVICE

Required electrical testing for pacing, sensing, impedance and defibrillation will be completed

Intervention/Treatment (LEADR)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (55)

LEADR: Heart Center Research

Huntsville, Alabama, 35801, United States

Location

LEADR LBBAP: Torrance Memorial Medical Center

Torrance, California, 90505, United States

Location

LEADR: Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

LEADR: University of South Florida

Tampa, Florida, 33606, United States

Location

LEADR & LEADR LBBAP: Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

LEADR: Saint Luke's Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

LEADR: Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

LEADR: Lourdes Cardiology Services

Voorhees Township, New Jersey, 08034, United States

Location

LEADR: Presbyterian Heart Group

Albuquerque, New Mexico, 87108, United States

Location

LEADR & LEADR LBBAP: South Shore University Hospital/Northwell Health

Bay Shore, New York, 11030, United States

Location

LEADR: TriHealth Hatton Research Institute

Cincinnati, Ohio, 45202, United States

Location

LEADR LBBAP: The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

LEADR: Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

LEADR LBBAP: The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

LEADR: Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, 18103, United States

Location

LEADR: Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

LEADR LBBAP: Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

LEADR& LEADR LBBAP: Vanderbilt University medical Center

Nashville, Tennessee, 37232, United States

Location

LEADR: Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

LEADR: Texas Health Fort Worth Hospital

Fort Worth, Texas, 76104, United States

Location

LEADR & LEADR LBBAP: University of Virginia Medical Center

Charlottesville, Virginia, 22903, United States

Location

LEADR & LEADR LBBAP: Virginia Commonwealth University Health System

Richmond, Virginia, 23298, United States

Location

LEADR LBBAP: Aurora St. Luke's Hospital

Milwaukee, Wisconsin, 53215, United States

Location

LEADR & LEADR LBBAP: The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

LEADR: Ashford Hospital

Ashford, South Australia, 8032, Australia

Location

LEADR & LEADR LBBAP: Royal Adelaide

Norwood, South Australia, 5000, Australia

Location

LEADR &LEADR LBBAP: Canberra Hospital

Garran, 2605, Australia

Location

LEADR: Universitätsklinikum Krems

Krems, Mitterweg, 3500, Austria

Location

LEADR LBBAP: Universitair Ziekenhuis Antwerpen

Edegem, Antwerp, 2650, Belgium

Location

LEADR: University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

LEADR: Southlake Regional Health Centre

Newmarket, Ontario, L3Y8C3, Canada

Location

LEADR & LEADR LBBAP: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Québec, Quebec, G1V 4G5, Canada

Location

LEADR: Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, 030000, China

Location

LEADR & LEADR LBBAP: West China Hospital of Sichuan University

Chengdu, China

Location

LEADR: Rigshospitalet

Copenhagen, 2100, Denmark

Location

LEADR: Centre Hospitalier Universitaire de Grenoble - Site Nord

La Tronche, 38700, France

Location

LEADR LBBAP: OC Santé - Clinique du Millénaire

Montpellier, 34960, France

Location

LEADR: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle

Rouen, 76031, France

Location

LEADR: Klinikum Bielefeld Kardiologie

Bielefeld, Bielefeld, 33604, Germany

Location

LEADR & LEADR LBBAP: Queen Mary Hospital

Hong Kong, Hong Kong

Location

LEADR: Princess Margaret Hospital

Lai Chi Kok, 999077, Hong Kong

Location

LEADR: Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

LEADR & LEADR LBBAP: Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan

Location

LEADR & LEADR LBBAP: National Cerebral and Cardiovascular Center

Suita, Osaka, 564-8565, Japan

Location

LEADR: Tokyo Women's Medical University Hospital

Shinjuku-Ku, Tokyo, 162-8666, Japan

Location

LEADR & LEADR LBBAP: Institut Jantung Negara - National Heart Institute

Kuala Lumpur, 50400, Malaysia

Location

LEADR LBBAP: Maastricht Universitair Medisch Centrum

Maastricht, Limburg, Netherlands

Location

LEADR LBBAP: Szpital Uniwersytecki w Krakowie

Krakow, Poland

Location

LEADR: Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz Cardiology

Carnaxide, 2790-134, Portugal

Location

LEADR: Klinicki Centar Srbije Pejsmejker centar

Belgrade, Serbia

Location

LEADR: Ng Teng Fong General Hospital

Singapore, Singapore, Singapore

Location

LEADR LBBAP: Hospital Universitario Virgen de las Nieves

Granada, Granada, 18014, Spain

Location

LEADR: Hospital Universitari Bellvitge

L'Hospitalet de Llobregat, Spain

Location

LEADR: Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

Location

LEADR & LEADR LBBAP: Imperial College Healthcare NHS Trust - Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39341436 DERIVED

MeSH Terms

Conditions

Tachycardia

Interventions

Electric Countershock

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• George Crossley, MD

  Vanderbilt University (LEADR)

  PRINCIPAL INVESTIGATOR

• Pugazhendhi Vijayaraman, MD

  Geisinger Medical Center (LEADR LBBAP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 28, 2021
• Study Start: June 21, 2021
• Primary Completion: September 3, 2025
• Study Completion: November 6, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); HK (2); AU (1); SG (1); US (23); FR (3); CA (3); DE (1); SE (1); GB (1); BE (1); ES (3); PT (1); PL (1); MY (1); IT (1); NL (1); JP (3); CN (2)