Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New heart pacing method tested against standard therapy in 850 patients

NCT ID NCT07069738

Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 4 times

Summary

This study compares a newer pacing method (Left Bundle Branch Area Pacing) with the standard cardiac resynchronization therapy for people with heart failure. About 850 adults with moderate to severe heart failure will take part. The goal is to see if the newer method reduces death, need for heart transplant, or heart-related complications.

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 850 people

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

Started

Oct 2025

Expected to finish

Nov 2029

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 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.

Inclusion Criteria: 1. Patient is age 18 years or above, or of legal age to give informed consent specific to state and national law 2. Patient meets a guideline-based indication for a de novo CRT-D device 3. Primary prevention indication for ICD therapy 4. Ischemic or nonischemic cardiomyopathy with LVEF ≤ 35% within 6 months of enrollment (LVEF must be assessed after the subject has been on GDMT for a minimum of 3 months) using an appropriate method of assessment (i.e. Echo, MRI, etc) 5. NYHA class II-IV despite maximally tolerated guideline directed medical therapy (GDMT)\* for at least 3 months \*GDMT is defined as all four drug classes listed below for at least 3 months prior to enrollment unless the investigator provides justification (e.g., contraindicated, not tolerated or cost): Renin Angiotensin System Inhibitors (ACE, ARB, or ARNI) Evidence based betablockers (metoprolol succinate, carvedilol, bisoprolol) Mineralocorticoid antagonists SGLT2 Inhibitor medications 6. Sinus rhythm with left bundle branch block (LBBB) defined as a QRS ≥ 140 ms in men and ≥ 130 ms in women with a predominantly negative deflection (QS or rS in lead V1 and mid QRS notching or slurring in at least two of the following leads: 1, aVL, V1, V2, V5, V6) within 3 months of enrollment 7. Patient is willing to participate in LATITUDE™ NXT remote patient monitoring 8. Patient is willing and capable of providing informed consent and participating in all testing associated with this investigation at an approved study site and at the protocol defined intervals (Note: Use of a legally authorized representative (LAR) is not allowed) 9. Patient plans to remain geographically stable (not permanently moving to another location) and can commit to all study participation requirements (procedure, follow-up visits and testing requirements) Exclusion Criteria: 1. Persistent or permanent atrial fibrillation (AF) within 3 months prior to enrollment and documented in the medical record 2. Frequent premature ventricular contractions (PVCs), atrial arrhythmias, and/or other causes of expected percentage of cardiac physiologic pacing (CPP) delivery below 95% at the time of enrollment 3. Non-LBBB conduction abnormalities (including right bundle branch block (RBB) or intraventricular conduction delay (IVCD)) within 3 months prior to enrollment 4. Complete, second degree or high degree atrioventricular (AV) block, that requires pacing at the time of enrollment 5. Current or prior pacemaker, ICD or CRT implant (Also includes non-transvenous ICD technology and leadless pacemakers) 6. Prior or planned mechanical or bioprosthetic tricuspid valve replacement 7. Currently receiving or previously received positive inotrope therapy within 3 months prior to enrollment 8. Unstable angina, acute myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention within 3 months prior to enrollment 9. History of heart transplantation or left ventricular assist device (LVAD) implantation 10. Less than 1 year of life expectancy at the time of enrollment 11. Anticipated heart transplantation or LVAD implantation within 1 year of enrollment 12. History of ventricular septal defect (VSD) 13. Complex congenital heart disease 14. Documented diagnosis of cardiac amyloidosis 15. Known occlusion or other reason limiting central venous access for transvenous leads 16. Women of childbearing potential who are, or plan to become, pregnant during the course of the study (assessment per investigator's discretion) 17. Patient currently requiring dialysis 18. Patient with known or suspected sensitivity to Dexamethasone Acetate (DXA) 19. Patient with contrast dye allergy or unwilling/able to undergo pre-treatment with steroids and/or diphenhydramine 20. Inability or refusal to comply with the follow-up schedule including subject living at such a distance from the investigational site that attending follow-up visits would be unusually difficult or burdensome 21. Patient is enrolled in any other concurrent study. Co-enrollment into other studies such as observational studies/registries needs prior written approval by BSC. Local mandatory governmental registries are accepted for co-enrollment without approval by BSC.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Heart failure - nyha ii - iv are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

heart failure systolic heart failure

As listed by the trial registrant

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

Heart failure - nyha ii - iv

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    40 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AdventHealth Tampa

    RECRUITING

    Tampa, Florida, 33613, United States

  • Alta Bates Summit Medical Center

    RECRUITING

    Oakland, California, 94609, United States

  • Arrhythmia Research Group

    RECRUITING

    Jonesboro, Arkansas, 72401, United States

  • Avera Heart Hospital of South Dakota

    RECRUITING

    Sioux Falls, South Dakota, 57108, United States

  • Baptist Hospital East Louisville

    RECRUITING

    Louisville, Kentucky, 40207, United States

  • Capital Cardiology Associates

    RECRUITING

    Albany, New York, 12211, United States

  • Cardiology Associates Medical Group, Inc.

    RECRUITING

    Ventura, California, 93003, United States

  • Cedars Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Centracare Heart and Vascular Center

    RECRUITING

    Saint Cloud, Minnesota, 56303, United States

  • Christus Trinity Mother Frances Health System

    RECRUITING

    Tyler, Texas, 75701, United States

  • Community Heart and Vascular Hospital

    RECRUITING

    Indianapolis, Indiana, 46250, United States

  • Corewell Health

    RECRUITING

    Grand Rapids, Michigan, 49525, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Heart Center Research, LLC

    RECRUITING

    Huntsville, Alabama, 35801, United States

  • Heart Hospital Baylor Plano

    RECRUITING

    Plano, Texas, 75093, United States

  • Mayo Clinic Phoenix

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Midwest Cardiovascular Institute

    RECRUITING

    Naperville, Illinois, 60540, United States

  • Mobile Infirmary Medical Center

    RECRUITING

    Mobile, Alabama, 36608, United States

  • Morristown Medical Center

    RECRUITING

    Morristown, New Jersey, 07932, United States

  • Mount Carmel Health System

    RECRUITING

    Columbus, Ohio, 43219, United States

  • New York Hospital Queens

    RECRUITING

    Flushing, New York, 11355, United States

  • OhioHealth Research and Innovation Institute-Riverside Methodist Hospital

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Pacific Heart Institute

    RECRUITING

    Santa Monica, California, 90404, United States

  • Penn Presbyterian Medical Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Piedmont Hospital

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Rochester General Hospital

    RECRUITING

    New York, New York, 14621, United States

  • SUNY-Upstate Medical University

    RECRUITING

    Syracuse, New York, 13057, United States

  • Sanger Heart and Vascular Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Sarasota Memorial Hospital

    RECRUITING

    Sarasota, Florida, 34239, United States

  • Scripps Memorial Hospital

    RECRUITING

    La Jolla, California, 92037, United States

  • Southcoast Physicians Group

    RECRUITING

    Fall River, Massachusetts, 02720, United States

  • St. Mary's Duluth Clinic Regional Heart Center

    RECRUITING

    Duluth, Minnesota, 55805, United States

  • St.Thomas Health

    RECRUITING

    Nashville, Tennessee, 37205, United States

  • Torrance Medical Center

    RECRUITING

    Torrance, California, 90505, United States

  • University of Chicago

    RECRUITING

    Hinsdale, Illinois, 60521, United States

  • University of Iowa Hospitals and Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Michigan Hospitals

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Washington Hospital Center

    RECRUITING

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

  • Weill Cornell Medical University

    RECRUITING

    New York, New York, 10021, United States

More trials for these conditions

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