Evaluation of Left Bundle Branch Area Pacing As A Rescue Strategy for Cardiac Resynchronization Therapy Non-Response

Description

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.

Conditions

Systolic Heart Failure, Heart Failure With Reduced Ejection Fraction, CRT Non-Response, Left Bundle Branch Area Pacing

Study Overview

Study Details

Study overview

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.

Evaluation of Left Bundle Branch Area Pacing As A Rescue Strategy for Cardiac Resynchronization Therapy Non-response in Patients With Heart Failure: A Randomized Controlled Trial

Evaluation of Left Bundle Branch Area Pacing As A Rescue Strategy for Cardiac Resynchronization Therapy Non-Response

Condition
Systolic Heart Failure
Intervention / Treatment

-

Contacts and Locations

Minneapolis

Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis, Minnesota, United States, 55417-2309

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Lack of improvement in New York Heart Association (NYHA) class
  • * Lack of LVEF increase by \> 5%
  • * Lack of decrease in LVESV by \> 15%
  • * 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

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

Selma D Carlson, MD, PRINCIPAL_INVESTIGATOR, Minneapolis VA Health Care System, Minneapolis, MN

Study Record Dates

2028-03-31