Evaluation of Left Bundle Branch Area Pacing As A Rescue Strategy for Cardiac Resynchronization Therapy Non-Response
NCT05884411 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2025-08-11
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.
Conditions
- Systolic Heart Failure
- Heart Failure With Reduced Ejection Fraction
- CRT Non-Response
- Left Bundle Branch Area Pacing
Interventions
- DEVICE
-
Left bundle branch area pacing
A cardiac pacing electrode is inserted into the left bundle branch area of the myocardium via a transvenous approach.
- DIAGNOSTIC_TEST
-
Cardiac MRI
A diagnostic imaging test using magnetic resonance imaging to evaluate cardiac function.
Sponsors & Collaborators
-
VA Office of Research and Development
lead FED
Principal Investigators
-
Selma D Carlson, MD · Minneapolis VA Health Care System, Minneapolis, MN
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-30
- Primary Completion
- 2025-08-05
- Completion
- 2025-08-05
- FDA Device
- Yes
Countries
- United States
Study Locations
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