An interventional study of LBBAP Therapy and LOT-CRT in Heart Failure and Systolic Bundle Branch Block, Left, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Medtronic Cardiac Rhythm and Heart Failure (part of Medtronic) · Not applicable, Interventional, and Treatment
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
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 110 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 240 studies on the registry; 4 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 18 (95%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LBBAP therapy for 6 months followed by LOT-CRT for 6 months
Device: LBBAP Therapy · Device: LOT-CRT
LOT-CRT for 6 months followed by LBBAP therapy for 6 months
Device: LBBAP Therapy · Device: LOT-CRT
Device: ICD · Device: LOT-CRT
CRT-D programmed for LBBAP (LV lead OFF)
CRT-D programmed for LOT-CRT (LBBAP + LV lead ON)
ICD programmed for LBBAP
CRT-D programmed for LOT-CRT (LBBAP + LV lead ON)
Left ventricular ejection fraction (LVEF)
Change in LVEF assessed by echocardiography during each therapy period (baseline to 6 months, 6 months to 12 months).
Time frame: 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).
Time frame: Baseline, 6 months, 12 months
Left ventricular ejection fraction (LVEF)
Change in LVEF assessed by echocardiography from baseline to 6 months
Time frame: Baseline, 6 months
Left ventricular end-systolic volume (LVESV)
Change in LVESV assessed by echocardiography from baseline to 6 months.
Time frame: Baseline, 6 months
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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