WITHDRAWN

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-04-30
Study Completion:2025-08-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:WITHDRAWN

Study ID

NCT05884411

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Lack of improvement in New York Heart Association (NYHA) class
  2. * Lack of LVEF increase by \> 5%
  3. * Lack of decrease in LVESV by \> 15%
  1. * Unable to understand or provide informed consent
  2. * Unable or unwilling to participate in the protocol or comply with any of its components
  3. * Pregnant women
  4. * Known cancer patients, actively receiving chemotherapy
  5. * Patients unable to pass MRI safety screening (intra-orbital metallic foreign bodies, severe claustrophobia, etc)
  6. * Patients with anatomical difficulties for implanting LBBAP
  7. * Patients with high risk of procedure-related infection
  8. * Immunocompromised patients

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: VA Office of Research and Development

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-30
Study Completion Date2025-08-05

Study Record Updates

Study Start Date2023-04-30
Study Completion Date2025-08-05

Terms related to this study

Keywords Provided by Researchers

  • Heart Failure
  • CRT
  • LBBAP
  • Non-response
  • Cardiac MRI
  • CMR
  • Left bundle branch area pacing
  • cardiac resynchronization therapy

Additional Relevant MeSH Terms

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