Heart Failure (HF), Left Bundle-Branch Block, Left Ventricular Ejection Fraction
Conditions
Brief 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.
Detailed description
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).
Interventions
DEVICELB-CRT
LB-CRT (DDD 60-130, LV lead turned off) (active intervention #1)
DEVICEBIV-CRT
BIV-CRT (DDD 60- 130, LV lead turned on) (active intervention #2).
Sponsors
Inova Health Care Services
Medtronic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
single arm crossover study
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in myocardial performance index (MPI) as compared to Baseline | Baseline and 3 month treatment period after each pacing mode | Myocardial performance index (MPI), a global measure of cardiac performance is defined using tissue Doppler imaging. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrett Atwater, MD
Inova Health Care Services
Outcome results
None listed