Angiography versus electrogram guidance for Bachmann bundle pacemaker lead placement
Angiography and Electrogram Guided Bachmann Bundle Pacing - ANGEL BBP
This study will try two ways to guide placement of an atrial pacemaker wire in the Bachmann bundle for people getting a permanent pacemaker or ICD to see which method leads to more successful placement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Geisinger Clinic Academic / other |
| Locations | 1 site (Wilkes-Barre, Pennsylvania) |
| Trial ID | NCT07110922 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center, randomized trial that will enroll 50 patients scheduled for permanent pacemaker or ICD implantation with an atrial lead. Participants are randomized to have Bachmann bundle pacing (BBP) lead placement guided primarily by angiographic contrast x-ray images versus guidance mainly by local electrograms and surface ECG criteria. Implantation uses a Medtronic 3830 lead with C304/C315 sheaths and confirmation of BBP by recorded Bachmann bundle potentials, paced P-wave morphology and duration, and fluoroscopic location in RAO/LAO views. During angiography-guided implants a 5–10 mL SVC angiogram through the delivery sheath will be used to map anatomy; procedural success rates and feasibility will be compared between groups.
Who should consider this trial
Good fit: Adults over 18 who are scheduled for a permanent pacemaker or ICD that requires an atrial pacing lead and who can give informed consent and attend follow-up are the ideal candidates.
Not a fit: Patients with persistent atrial fibrillation at the time of implant, significant renal dysfunction (creatinine >3.0 mg/dL), pregnancy, or inability to receive contrast or consent are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could increase the accuracy and success rate of placing atrial leads in the Bachmann bundle, potentially improving atrial pacing performance.
How similar studies have performed: Small observational series and single-center reports have shown feasibility of Bachmann bundle pacing, but randomized comparisons of angiography-guided versus electrogram-guided placement are limited and this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Wilkes-Barre, Pennsylvania
- Geisinger Wyoming Valley — Wilkes-Barre, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Pugazhendhi Vijayaraman, MD — Geisinger Clinic
- Study coordinator: Pugazhendhi Vijayaraman, MD
- Email: pvijayaraman1@geisinger.edu
- Phone: 570-808-6020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.