Angiography and Electrogram Guided Bachmann Bundle Pacing

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, fluoroscopic locations on right anterior oblique (RAO) and left anterior oblique (LAO) projections.

During implant procedure, 5-10 ml of contrast will be used to perform inferior superior vena cava (SVC) angiogram via the lead delivery sheath in RAO and LAO views. The pacing lead will be then implanted using these images as guidance along with recording of local electrograms from the pacing lead.

The study team will randomize 50 patients who satisfy inclusion and exclusion criteria. The study team will compare the difference in procedural success between Angiography and Electrogram guided BBP and Electrogram/ECG only guided BBP patients.

• Angiography only (Diagnostic test): Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region
• Angiography and ECG (Diagnostic test): Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region and correlate with electrogram guidance for BBP

Primary outcomes

• Success of Bachmann bundle pacing using angiography at implant [Perioperative]
• Change in implant procedure duration [Perioperative]: Change in implant procedure duration between the two arms

Secondary outcomes

• Atrial pacing parameters [3 month follow up]: atrial pacing parameters include threshold, sensing and impedance measured by device interrogation
• Paced P-wave morphology compared to native P-waves [3 month follow up]: P-wave morphology is measured via ECG at follow up and compared to native P-waves from baseline ECG
• Paced P-wave duration compared to native P-waves [3 month follow up]: P-wave duration is measured via ECG at follow up and compared to native P-waves from baseline ECG

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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 serum Creatinine >3.0 mg/dl

• Pugazhendhi Vijayaraman, MD, Principal investigator, Geisinger Clinic