NCT05884411

Brief Summary

This study aims to investigate whether the investigators can improve heart function in patients with heart failure who have undergone cardiac resynchronization therapy, but have not had an improvement in their heart function at least one year after the procedure. The investigators will evaluate whether placing a new pacing lead (electrode) in a different part of the heart may increase heart function and decrease heart failure symptoms.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

April 30, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2025

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

2.3 years

First QC Date

April 28, 2023

Last Update Submit

August 5, 2025

Conditions

Systolic Heart FailureHeart Failure With Reduced Ejection FractionCRT Non-ResponseLeft Bundle Branch Area Pacing

Keywords

Heart FailureCRTLBBAPNon-responseCardiac MRICMRLeft bundle branch area pacingcardiac resynchronization therapy

Outcome Measures

Primary Outcomes (1)

  • Left ventricular ejection fraction by echocardiography

    CRT non-response will be evaluated by echocardiography to assess left ventricular ejection fraction (LVEF). LVEF is reported as a percent.

    6 months

Secondary Outcomes (2)

  • Left ventricular ejection fraction by cardiac MRI

    6 months

  • Interventricular mechanical delay measurement by 2D speckle-tracking echocardiography

    6 months

Study Arms (2)

LBBAP

EXPERIMENTAL

This arm will investigate improvement in cardiac function following placement of the LBBA pacing electrode in half the patients.

Device: Left bundle branch area pacing

Cardiac MRI with devices

EXPERIMENTAL

This arm will investigate the feasibility of cardiac MRI to be used to measure cardiac function in patients with cardiac devices.

Diagnostic Test: Cardiac MRI

Interventions

Left bundle branch area pacingDEVICE

A cardiac pacing electrode is inserted into the left bundle branch area of the myocardium via a transvenous approach.

Also known as: LBBAP
LBBAP
Cardiac MRIDIAGNOSTIC_TEST

A diagnostic imaging test using magnetic resonance imaging to evaluate cardiac function.

Also known as: CMR
Cardiac MRI with devices

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All Veterans in this study will have undergone CRT at least 12 months prior to enrollment and determined to have non-response by all the following criteria:
  • Lack of improvement in New York Heart Association (NYHA) class
  • Lack of LVEF increase by \> 5%
  • Lack of decrease in LVESV by \> 15%

You may not qualify if:

  • Unable to understand or provide informed consent
  • Unable or unwilling to participate in the protocol or comply with any of its components
  • Pregnant women
  • Known cancer patients, actively receiving chemotherapy
  • Patients unable to pass MRI safety screening (intra-orbital metallic foreign bodies, severe claustrophobia, etc)
  • Patients with anatomical difficulties for implanting LBBAP
  • Patients with high risk of procedure-related infection
  • Immunocompromised patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location

MeSH Terms

Conditions

Heart Failure, SystolicHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Selma D Carlson, MD

    Minneapolis VA Health Care System, Minneapolis, MN

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomized to either receive the new pacing lead in the left bundle branch area or continue current cardiac therapy (CRT) with biventricular CRT
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2023

First Posted

June 1, 2023

Study Start

April 30, 2023

Primary Completion

August 5, 2025

Study Completion

August 5, 2025

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)