RecruitingHeart Failure - NYHA II - IV

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

Eligible age

18+ yrs

Accepts

All genders

Locations

19 states

Healthy volunteers

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About this study

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.

Sponsor: Boston Scientific Corporation

You may qualify if…

✓ 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

You may not qualify if…

✕ 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