Angiography and Electrogram Guided Bachmann Bundle Pacing ((ANGEL-BBP))

Angiography and Electrogram Guided Bachmann Bundle Pacing - ANGEL BBP

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases
• Intervention / Treatment: Diagnostic test: Angiography only; Diagnostic test: Angiography and ECG

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pugazhendhi Vijayaraman, MD; Phone Number: 570-808-6020; Email: pvijayaraman1@geisinger.edu

Study Locations

• United States
  • Pennsylvania
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Recruiting
      • Geisinger Wyoming Valley
      • Contact: Vijayaraman Pugazhendi, MD; Phone Number: 5708086020; Email: pvijayaraman1@geisinger.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Angiography only	Diagnostic test: Angiography only; Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region
Experimental: Angiography and ECG	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of Bachmann bundle pacing using angiography at implant		Perioperative
Change in implant procedure duration	Change in implant procedure duration between the two arms	Perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial pacing parameters	atrial pacing parameters include threshold, sensing and impedance measured by device interrogation	3 month follow up
Paced P-wave morphology compared to native P-waves	P-wave morphology is measured via ECG at follow up and compared to native P-waves from baseline ECG	3 month follow up
Paced P-wave duration compared to native P-waves	P-wave duration is measured via ECG at follow up and compared to native P-waves from baseline ECG	3 month follow up

Collaborators and Investigators

• Sponsor: Pugazhendhi Vijayaraman
• Collaborators: Medtronic
• Investigators: Principal Investigator: Pugazhendhi Vijayaraman, MD, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2025
• Primary Completion (Estimated): September 26, 2027
• Study Completion (Estimated): December 26, 2027

Study Registration Dates

• First Submitted: June 24, 2025
• First Submitted That Met QC Criteria: August 1, 2025
• First Posted (Actual): August 8, 2025

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Radiography; Heart Function Tests; Electrodiagnosis; Electrocardiography; Angiography
• Other Study ID Numbers: 2025-0403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared in an identifiable way.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No