Angiography and Electrogram Guided Bachmann Bundle Pacing

NCT ID: NCT07110922

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2027-12-26

Brief Summary

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.

Conditions

Heart Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Angiography only

Group Type: EXPERIMENTAL

Angiography only

Intervention Type: DIAGNOSTIC_TEST

Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region

Angiography and ECG

Group Type: EXPERIMENTAL

Angiography and ECG

Intervention Type: DIAGNOSTIC_TEST

Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region and correlate with electrogram guidance for BBP

Interventions

Angiography only

Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Pugazhendhi Vijayaraman

OTHER

Sponsor Role: lead

Responsible Party

Pugazhendhi Vijayaraman

Director, Cardiac Electrophysiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Pugazhendhi Vijayaraman, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger Wyoming Valley

Wilkes-Barre, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Pugazhendhi Vijayaraman, MD

Role: CONTACT

pvijayaraman1@geisinger.edu

570-808-6020

Facility Contacts

Vijayaraman Pugazhendi, MD

Role: primary

pvijayaraman1@geisinger.edu

5708086020

Other Identifiers

2025-0403

Identifier Type: -

Identifier Source: org_study_id