REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)

Not Applicable

Active, not recruiting

• Conditions: Heart Failure (HF); Left Bundle-Branch Block; Left Ventricular Ejection Fraction
• Interventions: Device: LB-CRT; Device: BIV-CRT

• Registration Number: NCT05652218
• Lead Sponsor: Inova Health Care Services

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).

Study Timeline

• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-15
• Study Start: 2023-02-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03
• Primary Completion: 2025-06-05
• Study Completion: 2025-06-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	BIV-CRT	LB-CRT - Left Bundle Cardiac Resynchronization Therapy, Participants will spend 3 months in this group
Sequence 2	BIV-CRT	BiV-CRT - Biventricular Pacing Cardiac Resynchronization Therapy. Participants will spend 3 months in this group
Sequence 1	LB-CRT	LB-CRT - Left Bundle Cardiac Resynchronization Therapy, Participants will spend 3 months in this group
Sequence 2	LB-CRT	BiV-CRT - Biventricular Pacing Cardiac Resynchronization Therapy. Participants will spend 3 months in this group

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Inova Health System; 🇺🇸 Falls Church, Virginia, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States