Angiography and Electrogram Guided Bachmann Bundle Pacing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Angiography only, Angiography and ECG.
- Who it may be relevant to
- Registry conditions: Heart Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Angiography and Electrogram Guided Bachmann Bundle Pacing - ANGEL BBP
Overview
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.
Detailed 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, 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.
Interventions
- Diagnostic test Angiography only
Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region - Diagnostic test Angiography and ECG
Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region and correlate with electrogram guidance for BBP
Primary outcome measures
- Success of Bachmann bundle pacing using angiography at implant [Time frame: Perioperative]
- Change in implant procedure duration [Time frame: Perioperative]
Secondary outcome measures (3)
- Atrial pacing parameters [Time frame: 3 month follow up]
- Paced P-wave morphology compared to native P-waves [Time frame: 3 month follow up]
- Paced P-wave duration compared to native P-waves [Time frame: 3 month follow up]
Eligibility criteria
Inclusion criteria
- Patients > 18 years of age
- Patient with an indication for permanent pacemaker or ICD utilizing atrial pacing lead
- Patient is willing to comply with all study procedures and be available for the duration of the study.
Exclusion criteria
- Inability to provide informed consent
- Pregnant
- Enrolled in a concurrent study that may confound the results of this study.
- 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)
- Renal dysfunction with serum Creatinine >3.0 mg/dl
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Geisinger Wyoming Valley — Wilkes-Barre
Identifiers
NCT: NCT07110922 · 2025-0403