Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will compare two different methods to pace the heart to treat heart failure including:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT Cohort | Active Comparator | Participants will be randomized, implanted with a BSC CRT-D device using a Quadripolar lead, and device programmed to the respective cohort. |
|
| LBBA Cohort | Experimental | Participants will be randomized, implanted with a BSC CRT-D using the INGEVITY+ pace/sense lead implanted in the LBBA, and device programmed to the respective cohort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT-D with a Quadripolar LV lead | Device | Participants randomized to this cohort will receive a BSC system: CRT-D, Right Atrial Lead (RA), Defibrillation Lead (RV), Quadripolar LV Lead. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Through study completion, up to maximum of 5 years |
| System-related complication-free rate | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Win ratio composite assessment | Win Ratio Ranking: 1) Death 2) Heart Transplant/LVAD 3) Number of Heart Failure (HF) events (includes in-patient, out-patient and HF re-admission 4) Number of VT/VF episodes requiring device therapy or external defibrillation/cardioversion (one episode per 24 hours 5) Change in MLHFQ (Minnesota Living with Heart Failure Questionnaire) quality of life | Through study completion, up to a maximum of 5 years |
Not provided
Inclusion Criteria:
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 LATITUDEâ„¢ 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)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacqueline Beaulieu | Contact | 1-800-227-3422 | jacqueline.beaulieu@bsci.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Research, LLC | Recruiting | Huntsville | Alabama | 35801 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CRT-D with INGEVITY+ pace/sense lead | 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) |
|
| 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. | 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. | Through study completion, up to a maximum of 5 years |
| System-related complication-free rate between randomized arms | System-related complication-free rate of LBBAP at 12 months. This will compare the two randomized arms. | 12 months |
| Mobile Infirmary Medical Center | Recruiting | Mobile | Alabama | 36608 | United States |
|
| Arrhythmia Research Group | Recruiting | Jonesboro | Arkansas | 72401 | United States |
|
| Scripps Memorial Hospital | Recruiting | La Jolla | California | 92037 | United States |
|
| Cedars Sinai Medical Center | Recruiting | Las Angeles | California | 90048 | United States |
|
| Alta Bates Summit Medical Center | Recruiting | Oakland | California | 94609 | United States |
|
| Pacific Heart Institute | Recruiting | Santa Monica | California | 90404 | United States |
|
| Torrance Medical Center | Recruiting | Torrance | California | 90505 | United States |
|
| Cardiology Associates Medical Group, Inc. | Recruiting | Ventura | California | 93003 | United States |
|
| Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
|
| Sarasota Memorial Hospital | Recruiting | Sarasota | Florida | 34239 | United States |
|
| AdventHealth Tampa | Recruiting | Tampa | Florida | 33613 | United States |
|
| Emory University Hospital | Recruiting | Altanta | Georgia | 30322 | United States |
|
| University of Chicago | Recruiting | Hinsdale | Illinois | 60521 | United States |
|
| Midwest Cardiovascular Institute | Recruiting | Naperville | Illinois | 60540 | United States |
|
| Community Heart and Vascular Hospital | Recruiting | Indianapolis | Indiana | 46250 | United States |
|
| University of Iowa Hospitals and Clinics | Recruiting | Iowa City | Iowa | 52242 | United States |
|
| Baptist Hospital East Louisville | Recruiting | Louisville | Kentucky | 40207 | United States |
|
| Southcoast Physicians Group | Recruiting | Fall River | Massachusetts | 02720 | United States |
|
| Corewell Health | Recruiting | Grand Rapids | Michigan | 49525 | United States |
|
| St. Mary's Duluth Clinic Regional Heart Center | Recruiting | Duluth | Minnesota | 55805 | United States |
|
| Centracare Heart and Vascular Center | Recruiting | Saint Cloud | Minnesota | 56303 | United States |
|
| Morristown Medical Center | Recruiting | Morristown | New Jersey | 07932 | United States |
|
| New York Hospital Queens | Recruiting | Flushing | New York | 11355 | United States |
|
| Weill Cornell Medical University | Recruiting | New York | New York | 10021 | United States |
|
| Rochester General Hospital | Recruiting | New York | New York | 14621 | United States |
|
| SUNY-Upstate Medical University | Recruiting | Syracuse | New York | 13057 | United States |
|
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
|
| OhioHealth Research and Innovation Institute-Riverside Methodist Hospital | Recruiting | Columbus | Ohio | 43214 | United States |
|
| Mount Carmel Health System | Recruiting | Columbus | Ohio | 43219 | United States |
|
| Penn Presbyterian Medical Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| Avera Heart Hospital of South Dakota | Recruiting | Sioux Falls | South Dakota | 57108 | United States |
|
| St.Thomas Health | Recruiting | Nashville | Tennessee | 37205 | United States |
|
| Heart Hospital Baylor Plano | Recruiting | Plano | Texas | 75093 | United States |
|
| Christus Trinity Mother Frances Health System | Recruiting | Tyler | Texas | 75701 | United States |
|
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided