- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07110922
ANGEL BBP: Guided Pacing for Heart Rhythm Disorders
The ANGEL BBP clinical trial explores an innovative approach to pacemaker implantation for patients with heart rhythm disorders. This important study compares two different guidance methods for placing pacing leads in a specific area of the heart called the Bachmann bundle (BBP). The research team aims to determine whether using angiography (a special X-ray technique with contrast dye) combined with electrocardiograms (ECG) leads to better outcomes than using ECG guidance alone.
For patients requiring pacemakers or implantable cardioverter-defibrillators (ICDs) with atrial pacing leads, this study could lead to more precise lead placement techniques. The Bachmann bundle is a special pathway in the heart's electrical system, and pacing this area may offer advantages over traditional pacing locations. The study will involve 50 adult participants who will be randomly assigned to one of two groups: one using angiography plus ECG guidance, and another using ECG guidance alone.
During the procedure, doctors will use small amounts of contrast dye to visualize the superior vena cava (a major vein near the heart) from different angles. This helps identify the optimal location for lead placement in the Bachmann bundle area. The research team will carefully track several important factors including: the success rate of lead placement, procedure duration, pacing thresholds, and electrical measurements of the heart's activity.
Participants will be followed for at least three months after their procedure. During follow-up visits, doctors will check the device settings and measure electrical signals from the heart (P-waves) to compare with the patient's natural rhythm. These measurements will help determine if Bachmann bundle pacing maintains or improves the heart's natural electrical patterns.
This research is particularly significant because better lead placement techniques could lead to: more effective pacing with lower energy requirements, improved synchronization of the heart's upper chambers (atria), and potentially better long-term outcomes for pacemaker patients. The study also examines whether the additional imaging guidance shortens the overall procedure time, which could benefit both patients and healthcare providers.
Heart rhythm disorders affect millions of people worldwide, and pacemakers remain a crucial treatment for many patients. Research like the ANGEL BBP study helps advance our understanding of optimal device implantation techniques. As pacemaker technology continues to evolve, studies comparing different approaches to lead placement provide valuable information that can improve patient care and outcomes. The potential benefits of more precise lead positioning include longer battery life for devices, fewer complications, and better quality of life for patients living with cardiac devices.
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