Angiography versus electrogram guidance for Bachmann bundle pacemaker lead placement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.