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

Plain English Summary

Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure is a Not Applicable clinical trial sponsored by Boston Scientific Corporation studying Heart Failure - NYHA II - IV. This trial tests a new way to pace the heart, called Left Bundle Branch Area Pacing (LBBAP), against the current standard method (Cardiac Resynchronization Therapy or CRT) for treating heart failure. It is for adults with moderate to severe heart failure (NYHA Class II-IV) who have a specific type of heart rhythm problem (left bundle branch block) and a weakened heart pump. Participants will be randomly assigned to receive either the new LBBAP pacing or the standard CRT. Both involve implanting a device under the skin. The main alternative treatment for eligible patients is the standard CRT, which is already approved for heart failure. The trial aims to enroll 850 participants.

Official Summary

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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older who meet specific criteria for heart failure and have a weakened heart pump. Patients must have a specific heart rhythm issue called a left bundle branch block (LBBB) and have not responded well to standard heart failure medications. Individuals with certain other heart conditions, recent heart attacks, or those who have had a heart transplant or ventricular assist device are not eligible. You must be able to provide informed consent and commit to all study visits and procedures; a legal representative cannot provide consent for participation. This trial is studying Heart Failure - NYHA II - IV, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures whether the new pacing method reduces the risk of death, heart transplant, worsening heart failure, or dangerous heart rhythms compared to the standard treatment. The specific primary outcome measures are: Composite of reduction in all-cause mortality, heart transplant, left ventricular assist device, heart failure events, ventricular tachycardia/ventricular fibrillation requiring device therapy or external defibrillation/cardioversion. (Through study completion, up to maximum of 5 years); System-related complication-free rate (12 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it investigates a potentially more effective and less invasive way to improve heart function in patients with heart failure, addressing a significant unmet need in cardiac c This research targets Heart Failure - NYHA II - IV, where improved treatment options are needed.

Investor Insight

This trial, sponsored by Boston Scientific, explores a novel application for an FDA-approved pacing lead, potentially expanding the market for advanced heart failure therapies and indicating a competi The large enrollment target of 850 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if your specific type of heart failure and heart rhythm make you a candidate for this trial. Participation involves receiving a heart pacing device implant and attending regular follow-up appointments for up to 5 years. You will be randomly assigned to either the new pacing method or the standard treatment, and your heart function and overall health will be closely monitored. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: SINGLE
• Enrollment: 850 participants

Interventions

• DEVICE: CRT-D with a Quadripolar LV lead — Participants randomized to this cohort will receive a BSC system: CRT-D, Right Atrial Lead (RA), Defibrillation Lead (RV), Quadripolar LV Lead.
• DEVICE: CRT-D with INGEVITY+ pace/sense lead — 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)

Primary Outcomes

• Composite of reduction in all-cause mortality, heart transplant, left ventricular assist device, heart failure events, ventricular tachycardia/ventricular fibrillation requiring device therapy or external defibrillation/cardioversion. (Through study completion, up to maximum of 5 years)
• System-related complication-free rate (12 months)

Secondary Outcomes

• Win ratio composite assessment (Through study completion, up to a maximum of 5 years)
• Composite of reduction in all-cause mortality, heart transplant, left ventricular assist device, heart failure events, ventricular tachycardia/ ventricular fibrillation requiring device therapy or external defibrillation/cardioversion. (Through study completion, up to a maximum of 5 years)
• System-related complication-free rate between randomized arms (12 months)

Full 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.

Trial Locations

• Heart Center Research, LLC, Huntsville, Alabama, United States
• Mobile Infirmary Medical Center, Mobile, Alabama, United States
• Arrhythmia Research Group, Jonesboro, Arkansas, United States
• Scripps Memorial Hospital, La Jolla, California, United States
• Alta Bates Summit Medical Center, Oakland, California, United States
• Cardiology Associates Medical Group, Inc., Ventura, California, United States
• Sarasota Memorial Hospital, Sarasota, Florida, United States
• Emory University Hospital, Atlanta, Georgia, United States
• Midwest Cardiovascular Institute, Naperville, Illinois, United States
• Community Heart and Vascular Hospital, Indianapolis, Indiana, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Heart Failure
• Cardiomyopathy
• Left Ventricular Dysfunction
• Arrhythmia
• Bradycardia
• Heart Block
• Cardiac Resynchronization Therapy
• Implantable Cardioverter-Defibrillator (ICD)
• Ventricular Tachycardia
• Atrial Fibrillation

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