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New heart lead could improve pacing for thousands with heart failure

NCT ID NCT06830746

Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new type of wire (lead) for implantable heart devices like ICDs or CRT-Ds. The lead is designed to pace the heart's natural conduction system, which may work better than standard pacing. About 414 adults who need these devices will be followed for 3 months to check if the lead is safe and works well.

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

About 414 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

May 2028

An estimate. End dates often move.

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

18 to 99 years

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.

Inclusion Criteria: 1. Subject must meet current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following: 1. de novo Abbott ICD system implant (single or dual chamber) 2. de novo Abbott CRT-D system implant and is intended to also undergo left ventricle coronary sinus lead implant (for patients indicated for CRT-D according to locally approved indications) 2. Subject is ≥ 18 years of age or age of legal consent, whichever age is greater. 3. Subject is willing to undergo implant defibrillation testing if requested. Subjects with AF in whom defibrillation testing is required must have been on or willing to be on uninterrupted anticoagulation therapy before, during, and after the implant procedure. 4. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams. 5. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC. Exclusion Criteria: 1. Subject has had myocardial infarction or unstable angina within 40 days prior to signing consent 2. Subject has had recent cardiac revascularization (angioplasty, stent or bypass graft) in the 4 weeks prior to signing consent or planned within 3 months following consent 3. Subject has had any other therapeutic cardiovascular procedure (such as transcatheter aortic valve replacement, MitraClip, cardiac surgery, left atrial appendage closure, patent foramen ovale closure, or any ablation procedures) in the 3 months prior to signing consent or planned within 3 months following consent 4. Subject has had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of prior to signing consent 5. Subject has a life expectancy of less than 12 months 6. Subject has contraindications for standard RV transvenous and/or LBBAP lead placement (e.g., mechanical right heart valve) 7. Subject is contraindicated for ≤1mg Dexamethasone sodium phosphate. 8. Subject is pregnant or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence 9. Subject has an existing pacemaker (including a temporary pacing system), ICD, CRT, or cardiac contractility modulation (CCM) device or leads 10. Subject has any evidence of active infection or undergoing treatment for an infection 11. Subject is enrolled or planning to enroll in another clinical trial that might confound the results of the present study 12. Subject has moderate or severe aortic stenosis 13. Subject has ventricular septal defect (VSD) or had prior surgery on the interventricular septum that could impact LBBAP implant, such as septal myomectomy, ethanol septal ablation, VSD repair, etc 14. Subject has end-stage renal disease 15. Subject has NYHA IV classification 16. Subject has undergone cardiac transplantation or have a classification of Status 1 for cardiac transplantation or consideration for transplantation during the study follow-up period 17. Subject has had previously extracted leads 18. Subject has had an LV Assist Device 19. Subject has had a failed LBBAP lead implant Defibrillation testing exclusion criteria (these are part of general exclusion criteria when defibrillation testing is requested): 1. Subject has pre-existing or suspected pneumothorax during implant 2. Subject has current known intracardiac left atrial or Left Ventricular thrombus 3. Subject has severe proximal three-vessel or left main coronary artery disease without revascularization 4. Subject has Ejection Fraction less than 20% 5. Subject has recent stroke or transient ischemic attack (within the last 6 months) 6. Subject has known inadequate external defibrillation 7. Subject has any other known medical condition not listed that precludes their participation in the opinion of the investigator

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Conditions

The condition(s) this trial relates to.

heart failure ventricular tachycardia

As listed by the trial registrant

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

Heart failure Ventricular arrythmia

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Lombard, 20162, Italy

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401, United States

  • Banner University Medical Center Phoenix

    Phoenix, Arizona, 85006, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • CHRU Hopital de Pontchaillou

    Rennes, Brittan, 35033, France

  • CHU Trousseau

    Chambray-lès-Tours, Centre-Val de Loire, 37170, France

  • Changi General Hospital

    Singapore, Singapore

  • Erlanger Medical Center

    Chattanooga, Tennessee, 37403, United States

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • Heart Center Research LLC

    Huntsville, Alabama, 35801, United States

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014, Spain

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Hôpital Pitié Salpetrière

    Paris, Ile, 75013, France

  • Hôpitaux Universitaires de Genève

    Geneva, 1205, Switzerland

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602, United States

  • MUHC- Montreal General Hospital

    Montreal, H3G 1A4, Canada

  • Max Super Specialty Hospital

    New Delhi, National Capital Territory of Delhi, 110017, India

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Medical City Dallas Hospital

    Dallas, Texas, 75230, United States

  • Monash Health

    Clayton, Victoria, Australia

  • National Heart Centre Singapore

    Singapore, 169609, Singapore

  • New York Presbyterian Hospital/Cornell University

    New York, New York, 10021, United States

  • Ospedale S.S. Annunziata

    Taranto, Apulia, 74100, Italy

  • Premier Cardiology, Inc.

    Newport Beach, California, 92663, United States

  • Prince of Wales Hospital

    Hong Kong, Hong Kong

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, Australia

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Royal Adelaide Hospital

    Adelaide, South Australia, Australia

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • Sree Chitra Tirunal Institute for Medical Sciences & tech.

    Trivandrum, New Delhi, 695-011, India

  • Tan Tock Seng Hospital

    Singapore, Singapore

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • The Prince Charles Hospital

    Chermside, Queensland, Australia

  • University of California at San Diego (UCSD) Medical Center

    San Diego, California, 92103, United States

  • Velammal Medical College Hospital

    Madurai, Tmlnadu, 625009, India

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Other studies related to the condition(s) this trial covers.