Trials / Not Yet Recruiting
Not Yet RecruitingNCT07526896
Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LBBAP Therapy | CRT-D programmed for LBBAP (LV lead OFF) |
| DEVICE | LOT-CRT | CRT-D programmed for LOT-CRT (LBBAP + LV lead ON) |
Timeline
- Start date
- 2026-08-01
- Primary completion
- 2029-07-01
- Completion
- 2029-09-01
- First posted
- 2026-04-14
- Last updated
- 2026-04-14
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07526896. Inclusion in this directory is not an endorsement.