REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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).
Enrollment
Sex
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
21 participants in 2 patient groups
Trial contacts and locations
Loading...
Central trial contact
Tracy Plummer, BSN; Edwinia Battle, BSN
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal