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

REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT), a Phase I Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Left Bundle-Branch Block; Heart Failure (HF); Left Ventricular Ejection Fraction
• Intervention / Treatment: Device: LB-CRT; Device: BIV-CRT

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; LB-CRT - Left Bundle Cardiac Resynchronization Therapy, Participants will spend 3 months in this group	Device: LB-CRT; LB-CRT (DDD 60-130, LV lead turned off) (active intervention #1); Device: BIV-CRT; BIV-CRT (DDD 60- 130, LV lead turned on) (active intervention #2).
Experimental: Sequence 2; BiV-CRT - Biventricular Pacing Cardiac Resynchronization Therapy. Participants will spend 3 months in this group	Device: LB-CRT; LB-CRT (DDD 60-130, LV lead turned off) (active intervention #1); Device: BIV-CRT; BIV-CRT (DDD 60- 130, LV lead turned on) (active intervention #2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in myocardial performance index (MPI) as compared to Baseline	Myocardial performance index (MPI), a global measure of cardiac performance is defined using tissue Doppler imaging.	Baseline and 3 month treatment period after each pacing mode

Collaborators and Investigators

• Sponsor: Inova Health Care Services
• Collaborators: Medtronic
• Investigators: Principal Investigator: Brett Atwater, MD, Inova Health Care Services

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2023
• Primary Completion (Actual): February 28, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Block; Pathological Conditions, Signs and Symptoms; Heart Failure; Bundle-Branch Block
• Other Study ID Numbers: U22-04-4739

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes