Trial results for a study investigating the use of intra-procedural transthoracic echocardiogram to facilitate Left Bundle Branch Area Pacing (LBBAP) in Heart Failure patients were posted on ClinicalTrials.gov on 2025-10-01, with 33 participants enrolled.
Background
Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood to meet the body's needs. Treatment often involves medications and lifestyle changes, but for some patients, cardiac pacing devices are necessary to improve heart function and synchronize contractions. Left Bundle Branch Area Pacing (LBBAP) is an advanced pacing technique that aims to achieve more physiological ventricular activation compared to traditional right ventricular pacing. The success of LBBAP relies on precise lead placement. This study explored whether using intra-procedural transthoracic echocardiography could assist clinicians in accurately positioning the pacing lead, potentially reducing procedure time and exposure to X-ray imaging (fluoroscopy).
Trial design
This completed observational study enrolled 33 participants with Heart Failure to assess the utility of intra-procedural transthoracic echocardiogram during Left Bundle Branch Area Pacing (LBBAP). The study aimed to determine if echocardiogram use aids in wire location, reduces wire placement procedure time, and decreases X-ray imaging time. Participants were divided into groups: "EC-LBBAP Participant" (using intra-procedural echo), "EC-LBBAP Handheld Participant" (using handheld intra-procedural echo), and "Standard LBBP" (without intra-procedural echo assistance).
Key results
The trial results provided measurements related to the success rate of LBBAP utilization with intra-procedural echocardiogram and procedural durations:
- Success Rate of LBBAP Utilization With Intraprocedural Transthoracic Echocardiogram:
- In the "EC-LBBAP Participant" group, 19 participants achieved a positive success rate.
- In the "EC-LBBAP Handheld Participant" group, 10 participants achieved a positive success rate.
- Procedure Duration:
- The "EC-LBBAP Participant" group had a median procedure duration of 101 minutes (Standard Deviation 27).
- The "EC-LBBAP Handheld Participant" group had a median procedure duration of 89 minutes (Standard Deviation 29).
- The "Standard LBBP" group had a median procedure duration of 95 minutes (Standard Deviation 39).
- Fluoroscopy Duration:
- The "EC-LBBAP Participant" group had a median fluoroscopy duration of 8.9 minutes (Standard Deviation 7.9).
- The "EC-LBBAP Handheld Participant" group had a median fluoroscopy duration of 10.1 minutes (Standard Deviation 6.5).
- The "Standard LBBP" group had a median fluoroscopy duration of 13.5 minutes (Standard Deviation 8.5).
- Eligibility for Work-flow and Echocardiographic Procedures:
- 20 participants were determined eligible in the "EC-LBBAP Participant" group.
- 10 participants were determined eligible in the "EC-LBBAP Handheld Participant" group.
What this means
The findings suggest that the use of intra-procedural transthoracic echocardiogram, particularly the handheld variant, may offer benefits during Left Bundle Branch Area Pacing (LBBAP) procedures for patients with heart failure. The "EC-LBBAP Handheld Participant" group demonstrated a median procedure duration of 89 minutes, which was shorter than both the "EC-LBBAP Participant" group (101 minutes) and the "Standard LBBP" group (95 minutes). Furthermore, the fluoroscopy duration for the "EC-LBBAP Handheld Participant" group was 10.1 minutes, notably lower than the 13.5 minutes observed in the "Standard LBBP" group. These results indicate that incorporating intra-procedural echocardiography could potentially lead to reduced procedure times and decreased radiation exposure for patients undergoing LBBAP, while also supporting a positive success rate for lead placement.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for this observational study, titled "Intra-procedural Transthoracic EChocardiogram to Facilitate Left Bundle Branch Area Pacing (LBBAP)", were posted on 2025-10-01 on clinicaltrials.gov.