RecruitingNot applicable

Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares the safety and effectiveness of two ways to pace the heart in adults with heart failure who need a new heart pacing and shock device. One uses a wire in a vein on the heart’s surface; the other places a wire in the left bundle branch area, part of the heart’s electrical system. The second wire is FDA-approved for placement there, but not for treating heart failure.

This study will compare two different methods to pace the heart to treat heart failure including: 1. The current standard method of implanting a pacing lead in a vein on the surface of the left lower chamber of the heart (left ventricle) to deliver heart failure therapy. This method is called Cardiac Resynchronization Therapy (CRT). 2. The other method is using a lead implanted in the Left Bundle Branch Area (LBBA) of your heart. This method is called Left Bundle Branch Area Pacing or LBBAP. This lead is approved by the Food and Drug Administration (FDA) to be implanted in this area of the heart, but not to provide heart failure treatment.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18, or old enough under local law to give consent.
  • You meet medical guidelines for a new CRT-D device, which helps the heart’s chambers beat together and gives shocks to prevent sudden death.
  • Your heart muscle is weak, with or without damage from blocked heart arteries. A test within 6 months shows it pumps out 35% or less of its blood with each beat.
  • You still have heart failure symptoms rated class II–IV despite at least 3 months of the recommended medicines at doses you can tolerate.
  • You have taken four recommended types of heart failure medicines for at least 3 months before the heart pumping test and enrollment, unless the study doctor explains why you cannot.
  • A heart tracing within 3 months shows a normal starting rhythm and left bundle branch block, an electrical delay. It must meet the study’s timing and wave-pattern rules.
  • You agree to LATITUDE NXT home monitoring and can give your own informed consent. Someone else cannot consent for you.
  • You can attend all study visits and tests at an approved site and do not plan to move away permanently.

Who can't join

  • You have certain heart rhythm or electrical problems: ongoing atrial fibrillation within 3 months, frequent extra beats that would limit pacing below 95%, electrical delays other than left bundle branch block within 3 months, or heart block that needs pacing.
  • You have or previously had a pacemaker, heart shock device, or CRT device; have had or plan to have an artificial tricuspid heart valve; or have had a heart transplant or implanted heart pump.
  • Within 3 months, you received medicines that make the heart squeeze harder, had new or worsening chest pain or a heart attack, or had heart bypass surgery or a procedure to open heart arteries.
  • You are expected to live less than 1 year, or need a heart transplant or implanted heart pump within 1 year.
  • You have a history of a hole between the heart’s lower chambers, a complex heart defect from birth, abnormal protein buildup in the heart, or blocked veins or another problem preventing wire placement.
  • You are pregnant or plan to become pregnant during the study, or you need dialysis, a treatment that filters the blood.
  • You have a known or suspected reaction to dexamethasone acetate, an allergy to contrast dye, or cannot or will not take the required medicines before contrast dye.
  • You cannot follow the study visit schedule, or you are in another study without required approval. Some observation studies and registries may be allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (42)

AL

  • Heart Center Research, LLC · Huntsville, AL 35801John Jennings, Dr. · Study contactJohn Jennings, Dr. · Principal investigatorMore trials in Huntsville
  • Mobile Infirmary Medical Center · Mobile, AL 36608Ernest Matthew Quin, Dr. · Study contactErnest Matthew Quin, Dr. · Principal investigatorMore trials in Mobile

AR

  • Arrhythmia Research Group · Jonesboro, AR 72401Devi Nair, Dr. · Study contactDevi Nair, Dr. · Principal investigatorMore trials in Jonesboro

AZ

  • Mayo Clinic Phoenix · Phoenix, AZ 85054Mayank Sardana, MD · Study contactMayank Sardana, MD · Principal investigatorMore trials in Phoenix

CA

  • Scripps Memorial Hospital · La Jolla, CA 92037Nicolas Olson, MD · Study contactNicolas Olson, MD · Principal investigatorMore trials in La Jolla
  • Cedars Sinai Medical Center · Los Angeles, CA 90048Ashkan Ehdaie, MD · Study contactAshkan Ehdaie, MD · Principal investigatorMore trials in Los Angeles
  • Alta Bates Summit Medical Center · Oakland, CA 94609Rajan Shah, Dr. · Study contactRajan Shah, Dr. · Principal investigatorMore trials in Oakland
  • Pacific Heart Institute · Santa Monica, CA 90404Stephen Tang, MD · Study contactStephan Tang, MD · Principal investigatorMore trials in Santa Monica
  • Torrance Medical Center · Torrance, CA 90505Gene Kim, MD · Study contactGene Kim, MD · Principal investigatorMore trials in Torrance
  • Cardiology Associates Medical Group, Inc. · Ventura, CA 93003Jonathan Dukes, Dr. · Study contactJonathan Dukes, Dr. · Principal investigatorMore trials in Ventura

DC

  • Washington Hospital Center · Washington D.C., DC 20010Cyrus Hadadi, MD · Study contactCyrus Hadadi, MD · Principal investigatorMore trials in Washington D.C.

FL

  • Sarasota Memorial Hospital · Sarasota, FL 34239Antonio Moretta, Dr. · Study contactAntonio Moretta, Dr. · Principal investigatorMore trials in Sarasota
  • AdventHealth Tampa · Tampa, FL 33613Kenneth Yamamura, MD · Study contactKenneth Yamamura, MD · Principal investigatorMore trials in Tampa

GA

  • Piedmont Hospital · Atlanta, GA 30309Kavita Krishnasamy, MD · Study contactKavita Krishnasamy, MD · Principal investigatorMore trials in Atlanta
  • Emory University Hospital · Atlanta, GA 30322Anand Shah, MD · Study contactAnand Shah, MD · Principal investigatorMore trials in Atlanta

IA

  • University of Iowa Hospitals and Clinics · Iowa City, IA 52242Paari Dominic, MD · Study contactPaari Dominic, MD · Principal investigatorMore trials in Iowa City

ID

  • St. Luke's Idaho Cardiology Associates · Meridian, ID 83642Justice Oranefo, MD · Study contactJustice Oranefo, MD · Principal investigatorMore trials in Meridian

IL

IN

  • Community Heart and Vascular Hospital · Indianapolis, IN 46250Krishna Malineni, MD · Study contactKrishna Malineni, MD · Principal investigatorMore trials in Indianapolis

KY

  • Baptist Hospital East Louisville · Louisville, KY 40207Kevin Parrott, MD · Study contactKevin Parrott, MD · Principal investigatorMore trials in Louisville

MA

  • Southcoast Physicians Group · Fall River, MA 02720Arnoldas Giedrimas, MD · Study contactArnoldas Giedrimas, MD · Principal investigatorMore trials in Fall River

MI

  • University of Michigan Hospitals · Ann Arbor, MI 48109Thomas Crawford, MD · Study contactThomas Crawford, MD · Principal investigatorMore trials in Ann Arbor
  • Corewell Health · Grand Rapids, MI 49525Jawad Wassim, MD · Study contactJawad Wassim, MD · Principal investigatorMore trials in Grand Rapids

MN

  • St. Mary's Duluth Clinic Regional Heart Center · Duluth, MN 55805Christopher Latanich, MD · Study contactChristopher Latanich, MD · Principal investigatorMore trials in Duluth
  • Centracare Heart and Vascular Center · Saint Cloud, MN 56303More trials in Saint Cloud

NC

  • Sanger Heart and Vascular Institute · Charlotte, NC 28204Navid Nafissi, MD · Study contactNavid Nafissi, MD · Principal investigatorMore trials in Charlotte
  • Duke University Medical Center · Durham, NC 27710Daniel Friedman, MD · Study contactDaniel Friedman, MD · Principal investigatorMore trials in Durham

NJ

  • Morristown Medical Center · Morristown, NJ 07932Michael Katz, MD · Study contactMichael Katz, MD · Principal investigatorMore trials in Morristown

NY

  • Capital Cardiology Associates · Albany, NY 12211Rizwan Alimohammad, MD · Study contactRizwan Alimohammad, MD · Principal investigatorMore trials in Albany
  • New York Hospital Queens · Flushing, NY 11355Seth Goldbarg, Dr. · Study contactSeth Goldbarg, Dr. · Principal investigatorMore trials in Flushing
  • Weill Cornell Medical University · New York, NY 10021Jim Cheung, Dr. · Study contactJim Cheung, Dr. · Principal investigatorMore trials in New York
  • Rochester General Hospital · New York, NY 14621Dmitry Chuprun, MD · Study contactDmitry Chuprun, MD · Principal investigatorMore trials in New York
  • SUNY-Upstate Medical University · Syracuse, NY 13057Jorge Romero, MD · Study contactJorge Romero, MD · Principal investigatorMore trials in Syracuse

OH

  • OhioHealth Research and Innovation Institute-Riverside Methodist Hospital · Columbus, OH 43214Anish Amin, MD · Study contactAnish Amin, MD · Principal investigatorMore trials in Columbus
  • Mount Carmel Health System · Columbus, OH 43219Kamel Addo, MD · Study contactKamel Addo, MD · Principal investigatorMore trials in Columbus

PA

  • Penn Presbyterian Medical Center · Philadelphia, PA 19104John Bullinga, MD · Study contactJohn Bullinga, MD · Principal investigatorMore trials in Philadelphia

SD

  • Avera Heart Hospital of South Dakota · Sioux Falls, SD 57108Christopher Stanton, Dr. · Study contactChristopher Stanton, Dr. · Principal investigatorMore trials in Sioux Falls

TN

  • St.Thomas Health · Nashville, TN 37205Ricardo Lugo, MD · Study contactRicardo Lugo, MD · Principal investigatorMore trials in Nashville

TX

  • Heart Hospital Baylor Plano · Plano, TX 75093Mustafa Dohadwala, MD · Study contactMustafa Dohadwala, MD · Principal investigatorMore trials in Plano
  • Christus Trinity Mother Frances Health System · Tyler, TX 75701Stanislov Weiner, Dr. · Study contactStanislov Weiner, Dr. · Principal investigatorMore trials in Tyler

VA

  • University of Virginia Medical Center · Charlottesville, VA 22908Pamela Mason, MD · Study contactPamela Mason, MD · Principal investigatorMore trials in Charlottesville