NCT07526896Recruiting
Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 31 Mar 2026
- Start date
- 13 Oct 2026
- Primary completion date
- 31 Jul 2029
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Diseases
- Heart failure
- NCT number
- NCT07526896
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 13 Oct 2026 to the primary completion date, 31 Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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 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.
Other illness
- Subject has documented myocardial infarction before enrollment.
- Subject has contraindications for screw-in transvenous lead placement (e.g., mechanical right heart valve).
- Subject is post-heart transplantation or is actively listed on the transplantation list.
- 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.
Other
- 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 is implanted with a left ventricular assist device (LVAD).
- Subject has life expectancy of less than 12 months.
- Subject is pregnant or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Minneapolis Heart Institute Foundation Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.