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New ICD lead shows promise in heart rhythm study

NCT ID NCT04863664

Disease control Sponsor: Medtronic Cardiac Rhythm and Heart Failure Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new type of wire (lead) for implantable heart devices that deliver shocks to stop dangerous fast heart rhythms. Researchers checked how safe and effective the lead was in 998 people who needed a defibrillator or heart failure device. The lead was placed in a specific spot in the heart to see if it could reliably stop abnormal rhythms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

998 people

The number who actually took part.

Started

Jun 2021

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cardiac rhythm disease Tachycardia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tachyarrhythmia

Contacts and locations

Locations

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

    London, W12 0HS, United Kingdom

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

    Kuala Lumpur, 50400, Malaysia

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

    Québec, Quebec, G1V 4G5, Canada

  • LEADR & LEADR LBBAP: Kokura Memorial Hospital

    Kitakyushu, Fukuoka, 802-8555, Japan

  • LEADR & LEADR LBBAP: Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407, United States

  • LEADR & LEADR LBBAP: National Cerebral and Cardiovascular Center

    Suita, Osaka, 564-8565, Japan

  • LEADR & LEADR LBBAP: Queen Mary Hospital

    Hong Kong, Hong Kong

  • LEADR & LEADR LBBAP: Royal Adelaide

    Norwood, South Australia, 5000, Australia

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

    Bay Shore, New York, 11030, United States

  • LEADR & LEADR LBBAP: The Prince Charles Hospital

    Chermside, Queensland, 4032, Australia

  • LEADR & LEADR LBBAP: University of Virginia Medical Center

    Charlottesville, Virginia, 22903, United States

  • LEADR & LEADR LBBAP: Virginia Commonwealth University Health System

    Richmond, Virginia, 23298, United States

  • LEADR & LEADR LBBAP: West China Hospital of Sichuan University

    Chengdu, China

  • LEADR &LEADR LBBAP: Canberra Hospital

    Garran, 2605, Australia

  • LEADR LBBAP: Aurora St. Luke's Hospital

    Milwaukee, Wisconsin, 53215, United States

  • LEADR LBBAP: Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711, United States

  • LEADR LBBAP: Hospital Universitario Virgen de las Nieves

    Granada, Granada, 18014, Spain

  • LEADR LBBAP: Maastricht Universitair Medisch Centrum

    Maastricht, Limburg, Netherlands

  • LEADR LBBAP: OC Santé - Clinique du Millénaire

    Montpellier, 34960, France

  • LEADR LBBAP: Szpital Uniwersytecki w Krakowie

    Krakow, Poland

  • LEADR LBBAP: The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • LEADR LBBAP: The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • LEADR LBBAP: Torrance Memorial Medical Center

    Torrance, California, 90505, United States

  • LEADR LBBAP: Universitair Ziekenhuis Antwerpen

    Edegem, Antwerp, 2650, Belgium

  • LEADR& LEADR LBBAP: Vanderbilt University medical Center

    Nashville, Tennessee, 37232, United States

  • LEADR: Ashford Hospital

    Ashford, South Australia, 8032, Australia

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

    Bergamo, 24127, Italy

  • LEADR: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle

    Rouen, 76031, France

  • LEADR: Centre Hospitalier Universitaire de Grenoble - Site Nord

    La Tronche, 38700, France

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

    Carnaxide, 2790-134, Portugal

  • LEADR: Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • LEADR: Hartford Hospital

    Hartford, Connecticut, 06106, United States

  • LEADR: Heart Center Research

    Huntsville, Alabama, 35801, United States

  • LEADR: Hospital Universitari Bellvitge

    L'Hospitalet de Llobregat, Spain

  • LEADR: Hospital Universitario y Politécnico La Fe

    Valencia, 46026, Spain

  • LEADR: Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • LEADR: Klinicki Centar Srbije Pejsmejker centar

    Belgrade, Serbia

  • LEADR: Klinikum Bielefeld Kardiologie

    Bielefeld, Bielefeld, 33604, Germany

  • LEADR: Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18103, United States

  • LEADR: Lourdes Cardiology Services

    Voorhees Township, New Jersey, 08034, United States

  • LEADR: Ng Teng Fong General Hospital

    Singapore, Singapore, Singapore

  • LEADR: Presbyterian Heart Group

    Albuquerque, New Mexico, 87108, United States

  • LEADR: Princess Margaret Hospital

    Lai Chi Kok, 999077, Hong Kong

  • LEADR: Rigshospitalet

    Copenhagen, 2100, Denmark

  • LEADR: Saint Luke's Mid America Heart Institute

    Kansas City, Missouri, 64111, United States

  • LEADR: Shanxi Cardiovascular Hospital

    Taiyuan, Shanxi, 030000, China

  • LEADR: Southlake Regional Health Centre

    Newmarket, Ontario, L3Y8C3, Canada

  • LEADR: Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705, United States

  • LEADR: Texas Health Fort Worth Hospital

    Fort Worth, Texas, 76104, United States

  • LEADR: Tokyo Women's Medical University Hospital

    Shinjuku-Ku, Tokyo, 162-8666, Japan

  • LEADR: TriHealth Hatton Research Institute

    Cincinnati, Ohio, 45202, United States

  • LEADR: University of Calgary

    Calgary, Alberta, T2N 4N1, Canada

  • LEADR: University of South Florida

    Tampa, Florida, 33606, United States

  • LEADR: Universitätsklinikum Krems

    Krems, Mitterweg, 3500, Austria

  • LEADR: Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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