Improving heart function in veterans with heart failure who didn't respond to previous therapy
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
This study is testing a new heart pacing method to see if it can help veterans with heart failure who didn't get better after their previous treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05884411 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of left bundle branch area pacing (LBBAP) as a potential solution for veterans with heart failure who have not improved after cardiac resynchronization therapy (CRT). The research focuses on patients who have undergone CRT at least one year prior and have shown no significant improvement in heart function. By placing a new pacing lead in the left bundle branch area, the study aims to enhance electrical synchrony and potentially improve cardiac function and reduce heart failure symptoms. The study will also utilize cardiac MRI to assess heart function and structure.
Who should consider this trial
Good fit: Ideal candidates are veterans who have undergone CRT at least 12 months prior and have not experienced improvement in their heart function.
Not a fit: Patients who are unable to provide informed consent, have active cancer, or have anatomical difficulties for the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve heart function and quality of life for veterans suffering from heart failure.
How similar studies have performed: While traditional CRT has been widely studied, the specific approach of LBBAP for CRT non-response is emerging and may offer novel insights into treatment options.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Selma D Carlson, MD — Minneapolis VA Health Care System, Minneapolis, MN
- Study coordinator: Selma D Carlson, MD
- Email: selma.carlson@va.gov
- Phone: (612) 467-3662
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.