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

NCT05652218 | Active Not Recruiting FDA Device

• 1 other identifier: U22-04-4739
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Sequence 1

EXPERIMENTAL

LB-CRT - Left Bundle Cardiac Resynchronization Therapy, Participants will spend 3 months in this group

Device: LB-CRT; Device: BIV-CRT

Sequence 2

EXPERIMENTAL

BiV-CRT - Biventricular Pacing Cardiac Resynchronization Therapy. Participants will spend 3 months in this group

Device: LB-CRT; Device: BIV-CRT

Interventions

LB-CRT DEVICE

LB-CRT (DDD 60-130, LV lead turned off) (active intervention #1)

Sequence 1; Sequence 2

BIV-CRT DEVICE

BIV-CRT (DDD 60- 130, LV lead turned on) (active intervention #2).

Sequence 1; Sequence 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic: collaborator
• Inova Health Care Services: lead

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Inova Health System

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Heart Failure; Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brett Atwater, MD

  Inova Health Care Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Electrophysiology and Electrophysiology Research

Model Details: single arm crossover study

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: February 26, 2023
• Primary Completion: February 28, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)