| Registry | NCT07526896, acronym ACHIEVED LBBAP |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: double, treatment |
| Enrollment | 110 (Estimated) |
| Sponsor | Medtronic Cardiac Rhythm and Heart Failure (Industry) |
| Conditions | Heart Failure, Systolic Bundle Branch Block, Left |
| Interventions | LBBAP Therapy, LOT-CRT, ICD (Device) |
| Dates | start 2026-10-13, primary completion 2029-07-01 (estimated), completion 2029-09-01 (estimated), first posted 2026-04-14, last updated 2026-10-20 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Heart Failure All trials for Systolic Bundle Branch Block, Left All trials of LBBAP Therapy All trials of LOT-CRT
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). An observational treatment arm will include subjects who have not been randomized due to unsuccessful implant for real-world observational analysis
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Sequence 1 | Experimental | Device: LBBAP Therapy; Device: LOT-CRT | LBBAP therapy for 6 months followed by LOT-CRT for 6 months |
| Sequence 2 | Experimental | Device: LBBAP Therapy; Device: LOT-CRT | LOT-CRT for 6 months followed by LBBAP therapy for 6 months |
| Observational Treatment Arm | Experimental | Device: ICD; Device: LOT-CRT |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Subject meets current ACC/AHA/HRS guidelines for implantation of a CRT-D device. * Subject has documented LVEF ≤ 35% within 60 days of enrollment. * Subject meets the criteria for presence of Strauss-defined LBBB. * Subject meets NYHA classification II or III. * Subject is willing and able to provide written consent. * Subject is at least 18 years of age at the time of consent. * Subject is geographically stable and willing and able to complete study procedures, including follow-up visits. * The subject's medical records must be accessible by the enrolling site over the follow-up period. Exclusion Criteria: * Subject has documented myocardial infarction before enrollment. * Subject has non-LBBB conduction patterns such as Right Bundle Branch Block (RBBB) or non-specific IVCD. * Subject has 2nd or 3rd degree AV block. * Subject has persistent or permanent atrial fibrillation (AF) or atrial flutter (AFL). * Subject has intrinsic (non-paced) QRS duration ≤ 120ms. * Subject with previous or existing pacemaker (including transvenous and transcatheter pacing system), Implantable Cardioverter Defibrillator (ICD, transvenous) or CRT-D (transvenous) device or leads. * Subject has contraindications for screw-in transvenous lead placement (e.g., mechanical right heart valve). * Subject underwent valve surgery within 90 days prior to enrollment. * Subject is unable or unwilling to undergo baseline CMR imaging, if previously collected CMR images are unavailable or do not meet minimum acceptable criteria. * Subject is post-heart transplantation or is actively listed on the transplantation list. * Subject is implanted with a left ventricular assist device (LVAD). * Subject has severe renal disease. * Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure. * Subject has complex and uncorrected congenital heart disease. * Subject has life expectancy of less than 12 months. * Subject is pregnant or breastfeeding. * Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager.
| Facility | City | Country | Status |
|---|---|---|---|
| Minneapolis Heart Institute Foundation | Minneapolis, Minnesota | United States | Recruiting |