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

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · May 22, 2023

Keywords

ClinConnect Summary

**Trial Summary: Evaluation of Left Bundle Branch Area Pacing for Heart Failure Improvement**

This clinical trial is studying a new approach to help improve heart function in patients who have heart failure and did not see any benefits from a treatment called cardiac resynchronization therapy (CRT) over the past year. The researchers want to find out if placing a new pacing lead, which is a small device that helps control heartbeats, in a different area of the heart can help these patients feel better and improve how well their heart works.

To participate in this study, you must be a veteran who has had CRT at least one year ago and has not experienced any improvement in heart function. Specifically, you should not have seen changes in your heart failure symptoms or heart measurements that doctors use to assess heart function. If you fit these criteria and are interested in helping researchers learn more about this treatment, you can expect to undergo some assessments and procedures related to the study. It’s important to note that certain individuals, such as those who are pregnant or have specific health challenges, may not be eligible to participate. Overall, this trial aims to explore a potential new option for improving heart health in those who have not responded to standard treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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%
• Exclusion Criteria:
• • 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