Actively Recruiting
Angiography and Electrogram Guided Bachmann Bundle Pacing - ANGEL BBP
Led by Pugazhendhi Vijayaraman · Updated on 2025-09-22
50
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
P
Pugazhendhi Vijayaraman
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two methods for placing a wire in the Bachmann bundle of the heart in patients scheduled for a permanent pacemaker or defibrillator implant. The study compares the use of angiography alone versus angiography plus electrocardiogram (ECG) guidance to see which approach is more successful for this procedure. Both methods are FDA approved and used in standard clinical practice. Eligible patients will undergo Bachmann bundle pacing using specific leads and sheaths. During the implant procedure, 5-10 ml of contrast dye will be used to perform a superior vena cava angiogram in different views. The pacing lead will be implanted guided by these images and electrogram recordings. Patients will be randomly assigned to receive either angiography only or angiography combined with ECG guidance. The study will enroll 50 patients meeting inclusion and exclusion criteria. Participants will have their Bachmann bundle pacing success and procedure duration measured during the implant. Follow-up at 3 months will assess atrial pacing parameters and compare paced P-wave morphology and duration to native P-waves. The study includes monitoring through ECG, fluoroscopic imaging, and electrogram recordings. Participant involvement includes the implant procedure and follow-up assessments over several months to gather data on the pacing outcomes and procedure efficiency.
CONDITIONS
Brief Title
Angiography and Electrogram Guided Bachmann Bundle Pacing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age
- Need for permanent pacemaker or ICD with atrial pacing lead
- Willingness to comply with all study procedures and attend follow-up visits
You will not qualify if you...
- Unable to provide informed consent
- Pregnant
- Enrolled in another study that may affect results
- Persistent atrial fibrillation at implant if cardioversion is contraindicated
- Kidney dysfunction with serum Creatinine over 3.0 mg/dl
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure
Participants undergo Bachmann bundle pacing lead implantation guided by angiography and electrogram or angiography alone during a single implant procedure.
1 implant procedure visit (in-person)
Duration - 3 months
Participants attend follow-up visits to assess pacing parameters and paced P-wave morphology and duration.
Approximately 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
Actively Recruiting
Research Team
P
Pugazhendhi Vijayaraman, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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