Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
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)
Study 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.
Eligibility
Primary outcome measure(s)
- 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
The primary effectiveness endpoint is a composite of reduction in all-cause mortality, heart transplant, left ventricular assist device (LVAD), time to first heart failure (HF) events, time to first ventricular tachycardia (VT) / ventricular fibrillation (VF) requiring device therapy or external defibrillation/cardioversion. - System-related complication-free rate — 12 months
The primary safety endpoint is System-related complication-free rate of LBBAP at 12 months. This will be a single-arm analysis of the LBBAP group compared to a performance goal
Trial sites (42)
| Facility | City | Region | Status |
|---|---|---|---|
| Heart Center Research, LLC | Huntsville | Alabama | Recruiting |
| Mobile Infirmary Medical Center | Mobile | Alabama | Recruiting |
| Mayo Clinic Phoenix | Phoenix | Arizona | Recruiting |
| Arrhythmia Research Group | Jonesboro | Arkansas | Recruiting |
| Scripps Memorial Hospital | La Jolla | California | Recruiting |
| Cedars Sinai Medical Center | Los Angeles | California | Recruiting |
| Alta Bates Summit Medical Center | Oakland | California | Recruiting |
| Pacific Heart Institute | Santa Monica | California | Recruiting |
| Torrance Medical Center | Torrance | California | Recruiting |
| Cardiology Associates Medical Group, Inc. | Ventura | California | Recruiting |
| Washington Hospital Center | Washington D.C. | District of Columbia | Recruiting |
| Sarasota Memorial Hospital | Sarasota | Florida | Recruiting |
| AdventHealth Tampa | Tampa | Florida | Recruiting |
| Piedmont Hospital | Atlanta | Georgia | Recruiting |
| Emory University Hospital | Atlanta | Georgia | Recruiting |
| St. Luke's Idaho Cardiology Associates | Meridian | Idaho | Recruiting |
| University of Chicago | Hinsdale | Illinois | Recruiting |
| Midwest Cardiovascular Institute | Naperville | Illinois | Withdrawn |
| Community Heart and Vascular Hospital | Indianapolis | Indiana | Recruiting |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | Recruiting |
| Baptist Hospital East Louisville | Louisville | Kentucky | Recruiting |
| Southcoast Physicians Group | Fall River | Massachusetts | Recruiting |
| University of Michigan Hospitals | Ann Arbor | Michigan | Recruiting |
| Corewell Health | Grand Rapids | Michigan | Recruiting |
| St. Mary's Duluth Clinic Regional Heart Center | Duluth | Minnesota | Recruiting |
| Centracare Heart and Vascular Center | Saint Cloud | Minnesota | Withdrawn |
| Morristown Medical Center | Morristown | New Jersey | Recruiting |
| Capital Cardiology Associates | Albany | New York | Recruiting |
| New York Hospital Queens | Flushing | New York | Recruiting |
| Weill Cornell Medical University | New York | New York | Recruiting |
| Rochester General Hospital | New York | New York | Recruiting |
| SUNY-Upstate Medical University | Syracuse | New York | Recruiting |
| Sanger Heart and Vascular Institute | Charlotte | North Carolina | Recruiting |
| Duke University Medical Center | Durham | North Carolina | Recruiting |
| OhioHealth Research and Innovation Institute-Riverside Methodist Hospital | Columbus | Ohio | Recruiting |
| Mount Carmel Health System | Columbus | Ohio | Recruiting |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | Recruiting |
| Avera Heart Hospital of South Dakota | Sioux Falls | South Dakota | Recruiting |
| St.Thomas Health | Nashville | Tennessee | Recruiting |
| Heart Hospital Baylor Plano | Plano | Texas | Recruiting |
+ 2 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07069738 on ClinicalTrials.gov ↗ ← All trials in the USA