What this study is
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.
What's being tested
- CRT-D with a Quadripolar LV lead
Intervention · DEVICE
Participants randomized to this cohort will receive a BSC system: CRT-D, Right Atrial Lead (RA), Defibrillation Lead (RV), Quadripolar LV Lead.
- CRT-D with INGEVITY+ pace/sense lead
Intervention · DEVICE
Participants randomized to this cohort will receive a BSC system: CRT-D, Right Atrial Lead (RA), Defibrillation Lead (RV), INGEVITY+ pace/sense Lead (implanted in the LBBA)
Study details
- Sponsor
- Boston Scientific Corporation
- Conditions
- Heart Failure - NYHA II - IV
- Enrolling
- 850 people
- Starts
- 2025-10-22
- Est. completion
- 2029-11
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Patient is age 18 years or above, or of legal age to give informed consent specific to state and national law
- Patient meets a guideline-based indication for a de novo CRT-D device
- Primary prevention indication for ICD therapy
- 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)
- 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
- 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
- Patient is willing to participate in LATITUDE™ NXT remote patient monitoring
- 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)
- 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)
You can't join if
- Persistent or permanent atrial fibrillation (AF) within 3 months prior to enrollment and documented in the medical record
- 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
- Non-LBBB conduction abnormalities (including right bundle branch block (RBB) or intraventricular conduction delay (IVCD)) within 3 months prior to enrollment
- Complete, second degree or high degree atrioventricular (AV) block, that requires pacing at the time of enrollment
- Current or prior pacemaker, ICD or CRT implant (Also includes non-transvenous ICD technology and leadless pacemakers)
- Prior or planned mechanical or bioprosthetic tricuspid valve replacement
- Currently receiving or previously received positive inotrope therapy within 3 months prior to enrollment
- Unstable angina, acute myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention within 3 months prior to enrollment
- History of heart transplantation or left ventricular assist device (LVAD) implantation
- Less than 1 year of life expectancy at the time of enrollment
- Anticipated heart transplantation or LVAD implantation within 1 year of enrollment
- History of ventricular septal defect (VSD)
- Complex congenital heart disease
- Documented diagnosis of cardiac amyloidosis
- Known occlusion or other reason limiting central venous access for transvenous leads
- Women of childbearing potential who are, or plan to become, pregnant during the course of the study (assessment per investigator's discretion)
- Patient currently requiring dialysis
- Patient with known or suspected sensitivity to Dexamethasone Acetate (DXA)
- Patient with contrast dye allergy or unwilling/able to undergo pre-treatment with steroids and/or diphenhydramine
- 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
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (43)
40 openHeart Center Research, LLC
Huntsville, Alabama, United States
- John Jennings, Dr. · Contact
- John Jennings, Dr. · Principal investigator
RecruitingMobile Infirmary Medical Center
Mobile, Alabama, United States
- Ernest Matthew Quin, Dr. · Contact
- Ernest Matthew Quin, Dr. · Principal investigator
RecruitingMayo Clinic Phoenix
Phoenix, Arizona, United States
- Mayank Sardana, MD · Contact
- Mayank Sardana, MD · Principal investigator
RecruitingArrhythmia Research Group
Jonesboro, Arkansas, United States
- Devi Nair, Dr. · Contact
- Devi Nair, Dr. · Principal investigator
RecruitingScripps Memorial Hospital
La Jolla, California, United States
- Nicolas Olson, MD · Contact
- Nicolas Olson, MD · Principal investigator
RecruitingCedars Sinai Medical Center
Los Angeles, California, United States
- Ashkan Ehdaie, MD · Contact
- Ashkan Ehdaie, MD · Principal investigator
RecruitingAlta Bates Summit Medical Center
Oakland, California, United States
- Rajan Shah, Dr. · Contact
- Rajan Shah, Dr. · Principal investigator
RecruitingPacific Heart Institute
Santa Monica, California, United States
- Stephen Tang, MD · Contact
- Stephan Tang, MD · Principal investigator
RecruitingTorrance Medical Center
Torrance, California, United States
- Gene Kim, MD · Contact
- Gene Kim, MD · Principal investigator
RecruitingCardiology Associates Medical Group, Inc.
Ventura, California, United States
- Jonathan Dukes, Dr. · Contact
- Jonathan Dukes, Dr. · Principal investigator
RecruitingWashington Hospital Center
Washington D.C., District of Columbia, United States
- Cyrus Hadadi, MD · Contact
- Cyrus Hadadi, MD · Principal investigator
RecruitingSarasota Memorial Hospital
Sarasota, Florida, United States
- Antonio Moretta, Dr. · Contact
- Antonio Moretta, Dr. · Principal investigator
RecruitingAdventHealth Tampa
Tampa, Florida, United States
- Kenneth Yamamura, MD · Contact
- Kenneth Yamamura, MD · Principal investigator
RecruitingPiedmont Hospital
Atlanta, Georgia, United States
- Kavita Krishnasamy, MD · Contact
- Kavita Krishnasamy, MD · Principal investigator
RecruitingEmory University Hospital
Atlanta, Georgia, United States
- Anand Shah, MD · Contact
- Anand Shah, MD · Principal investigator
RecruitingSt. Luke's Idaho Cardiology Associates
Meridian, Idaho, United States
- Justice Oranefo, MD · Contact
- Justice Oranefo, MD · Principal investigator
RecruitingUniversity of Chicago
Hinsdale, Illinois, United States
- Shrinath Yeshwant, MD · Contact
- Shrinath Yeshwant, MD · Principal investigator
RecruitingCommunity Heart and Vascular Hospital
Indianapolis, Indiana, United States
- Krishna Malineni, MD · Contact
- Krishna Malineni, MD · Principal investigator
RecruitingUniversity of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
- Paari Dominic, MD · Contact
- Paari Dominic, MD · Principal investigator
RecruitingBaptist Hospital East Louisville
Louisville, Kentucky, United States
- Kevin Parrott, MD · Contact
- Kevin Parrott, MD · Principal investigator
RecruitingSouthcoast Physicians Group
Fall River, Massachusetts, United States
- Arnoldas Giedrimas, MD · Contact
- Arnoldas Giedrimas, MD · Principal investigator
RecruitingUniversity of Michigan Hospitals
Ann Arbor, Michigan, United States
- Thomas Crawford, MD · Contact
- Thomas Crawford, MD · Principal investigator
RecruitingCorewell Health
Grand Rapids, Michigan, United States
- Jawad Wassim, MD · Contact
- Jawad Wassim, MD · Principal investigator
RecruitingMorristown Medical Center
Morristown, New Jersey, United States
- Michael Katz, MD · Contact
- Michael Katz, MD · Principal investigator
RecruitingCapital Cardiology Associates
Albany, New York, United States
- Rizwan Alimohammad, MD · Contact
- Rizwan Alimohammad, MD · Principal investigator
RecruitingNew York Hospital Queens
Flushing, New York, United States
- Seth Goldbarg, Dr. · Contact
- Seth Goldbarg, Dr. · Principal investigator
RecruitingWeill Cornell Medical University
New York, New York, United States
- Jim Cheung, Dr. · Contact
- Jim Cheung, Dr. · Principal investigator
RecruitingRochester General Hospital
New York, New York, United States
- Dmitry Chuprun, MD · Contact
- Dmitry Chuprun, MD · Principal investigator
RecruitingSUNY-Upstate Medical University
Syracuse, New York, United States
- Jorge Romero, MD · Contact
- Jorge Romero, MD · Principal investigator
RecruitingSanger Heart and Vascular Institute
Charlotte, North Carolina, United States
- Navid Nafissi, MD · Contact
- Navid Nafissi, MD · Principal investigator
RecruitingDuke University Medical Center
Durham, North Carolina, United States
- Daniel Friedman, MD · Contact
- Daniel Friedman, MD · Principal investigator
RecruitingOhioHealth Research and Innovation Institute-Riverside Methodist Hospital
Columbus, Ohio, United States
- Anish Amin, MD · Contact
- Anish Amin, MD · Principal investigator
RecruitingMount Carmel Health System
Columbus, Ohio, United States
- Kamel Addo, MD · Contact
- Kamel Addo, MD · Principal investigator
RecruitingPenn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
- John Bullinga, MD · Contact
- John Bullinga, MD · Principal investigator
RecruitingGeisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States
- Pugazhendhi Vijayaraman, MD · Contact
- Pugazhendhi Vijayaraman, MD · Principal investigator
RecruitingAvera Heart Hospital of South Dakota
Sioux Falls, South Dakota, United States
- Christopher Stanton, Dr. · Contact
- Christopher Stanton, Dr. · Principal investigator
RecruitingSt.Thomas Health
Nashville, Tennessee, United States
- Ricardo Lugo, MD · Contact
- Ricardo Lugo, MD · Principal investigator
RecruitingHeart Hospital Baylor Plano
Plano, Texas, United States
- Mustafa Dohadwala, MD · Contact
- Mustafa Dohadwala, MD · Principal investigator
RecruitingChristus Trinity Mother Frances Health System
Tyler, Texas, United States
- Stanislov Weiner, Dr. · Contact
- Stanislov Weiner, Dr. · Principal investigator
RecruitingUniversity of Virginia Medical Center
Charlottesville, Virginia, United States
- Pamela Mason, MD · Contact
- Pamela Mason, MD · Principal investigator
RecruitingMidwest Cardiovascular Institute
Naperville, Illinois, United States
WithdrawnSt. Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, United States
WithdrawnCentracare Heart and Vascular Center
Saint Cloud, Minnesota, United States
Withdrawn
Study team
Sponsor
Boston Scientific Corporation
Study ID C2403
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.