Study Comparing Two Methods for Placing a Heart Pacing Wire in the Bachmann Bundle During Pacemaker or Defibrillator Implant

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.

Angiography and Electrogram Guided Bachmann Bundle Pacing