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
Not provided
This 2x2 randomized crossover feasibility study will evaluate the therapeutic value of adding pacing from the left ventricular lead to Left Bundle Branch Area Pacing (LBBAP) using a cardiac resynchronization therapy defibrillator (CRT-D). This combined therapy is known as Left Bundle Branch Optimized Cardiac Resynchronization Therapy (LOT-CRT) and will be compared to LBBAP therapy over sequential 6-month periods in CRT-indicated patients with LBBB. Primary and secondary outcomes are echocardiographic changes. Exploratory assessments will include NT-proBNP and subject-reported quality of life (KCCQ).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | LBBAP therapy for 6 months followed by LOT-CRT for 6 months |
|
| Sequence 2 | Experimental | LOT-CRT for 6 months followed by LBBAP therapy for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBBAP Therapy | Device | CRT-D programmed for LBBAP (LV lead OFF) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular ejection fraction (LVEF) | Change in LVEF assessed by echocardiography during each therapy period (baseline to 6 months, 6 months to 12 months). | Baseline, 6 months, 12 months |
| Left ventricular end-systolic volume (LVESV) | Change in LVESV assessed by echocardiography during each therapy period (baseline to 6 months, 6 months to 12 months). | Baseline, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular ejection fraction (LVEF) | Change in LVEF assessed by echocardiography from baseline to 6 months | Baseline, 6 months |
| Change in LVESV at 6 Months | Change in LVESV assessed by echocardiography from baseline to 6 months. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| D'Anne Kudlik | Contact | 763-526-1843 | danne.e.kudlik@medtronic.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| LOT-CRT |
| Device |
CRT-D programmed for LOT-CRT (LBBAP + LV lead ON) |
|
| Baseline, 6 months |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided