resynchronization comparison in lbbb and normal or mildly reduced ventricular function with crt (reinvent-crt)

Conditions: Left Ventricular Ejection Fraction; Heart Failure (HF); Left Bundle-Branch Block

Summary: primary objective - to determine if implantation of a permanent crt pacing device (with lb-crt, or conventional biv-crt with a coronary sinus lv lead) can improve electromechanical function, hf symptoms, and natriuretic peptide levels among patients with symptomatic hf, lvef \> 35%, and lbbb.

this pilot study will be a multicenter randomized controlled trial involving 20 medically stable outpatients with heart failure (hf), preserved or mildly reduced lvef (\>35%), and lbbb. patients will undergo implantation of a medtronic percepta crt-p with an atrial lead, left bundle branch area pacing (lbbap) lead, and a lv lead. they will then be randomly allocated in a 1:1 fashion to usual care plus lb-crt (ddd 60-130, lv lead turned off) (active intervention #1) or usual care plus biv-crt (ddd 60- 130, lv lead turned on) (active intervention #2).

Eligibility criteria:
inclusion criteria: * ability to understand and the willingness to sign a written informed consent form and hipaa authorization. * stated willingness to comply with all study procedures and availability for the duration of the study * male or female aged ≥18 years * strict lbbb defined as qrs duration ≥130ms in women and ≥140ms in men, a qs or rs complex in v1 and v2, as well as notching or qrs slurring in mid-qrs in ≥2 contiguous leads. * nyha ii/iii, ambulatory nyha iv, or nyha i hf with any prior history of hf symptom decompensation requiring hospitalization, ed visit, or outpatient visit for care with iv diuretic * lvef \>35% by clinically obtained echocardiogram overread by the study core-lab * demonstration of adequate echocardiographic images to allow for assessment of endpoints * on a stable guideline directed hf medical regimen * for females of reproductive potential: use of a highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation * ability to understand and the willingness to sign a written informed consent form and hipaa authorization. exclusion criteria: * patients with anticipated addition or titration of hf medical therapies (ace/arb/arni, beta blocker, mra, sglt2 inhibitor) during the duration of the study * treatment with another investigational drug or other intervention within 3 months * current unrevascularized coronary artery disease, unstable angina, acute mi, cabg, or pci within the past 3 months * significant non-functional mitral or aortic valvular disease (severe stenosis or regurgitation) * significant structural heart \[including hypertrophic cardiomyopathy (septal thickness ≥15 mm) or infiltrative cardiomyopathy (eg. amyloid)\] * current moderate to severe pulmonary hypertension (right ventricular systolic pressure of ≥40 mmhg) * oxygen dependent chronic lung disease * prolonged episodes of af (\>3 days or an af burden \>10%) within the preceding 3 months * presence of cardiac pacemaker or implantable cardioverter defibrillator * prior mechanical tricuspid valve replacement * pregnancy or lactation due to concerns about the effect of radiation from the pacemaker implantation procedure on the fetus * known allergic reactions to components of the pacemaker or leads * febrile illness within 3 days of trial enrollment * parents/guardians or participants who, in the opinion of the investigator, may be non-compliant with study schedules or procedures. * control participant exclusion criteria: same