Angiography and Electrogram Guided Bachmann Bundle Pacing - ANGEL BBP
Pugazhendhi Vijayaraman
Summary
People eligible for this study are scheduled to have a permanent pacemaker (PPM) or defibrillator device (ICD) implanted as part of their routine care. This device will also have a wire placed in the right atrium (RA) of the heart. As an alternative to the RA, the wire can also be placed in the Bachmann bundle (BB). This study is being done to compare two options to help place the wire in the Bachmann bundle. One option uses contrast dye and x-ray, and the other option uses electrocardiogram (ECG) and contrast dye and x-ray. We want to learn more about how well these options work in implanting the wire in the Bachmann bundle. Both of these options are FDA approved and used in standard practice.
Description
The ANGEL BBP study is a prospective, single-center, randomized, controlled research study. The study team will identify all patients who satisfy the inclusion and exclusion criteria. The study team will evaluate the feasibility and success rates of Angiography guided Bachmann bundle pacing (BBP) lead implantation compared to traditional approach. Eligible patients would undergo BBP using Medtronic 3830 lead and C304 or C315 family of sheaths. BBP will be confirmed at implant using Bachmann bundle potentials recorded from the lead, ECG 'P' wave morphology and duration during atrial pacing, fl…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Patients \> 18 years of age 2. Patient with an indication for permanent pacemaker or ICD utilizing atrial pacing lead 3. Patient is willing to comply with all study procedures and be available for the duration of the study. Exclusion Criteria: 1. Inability to provide informed consent 2. Pregnant 3. Enrolled in a concurrent study that may confound the results of this study. 4. Persistent atrial fibrillation at the time of implant (if cardioversion contraindicated at the time of implant, where BB mapping cannot be performed in sinus rhythm) 5. Renal dysfunction with ser…
Interventions
- Diagnostic TestAngiography only
Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region
- Diagnostic TestAngiography and ECG
Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region and correlate with electrogram guidance for BBP
Location
- Geisinger Wyoming ValleyWilkes-Barre, Pennsylvania